Data / Medical devices / United States / Qualigen, Inc.

Qualigen, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 13 510(k) clearances

Name: Qualigen, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Qualigen, Inc. is registered with the FDA (registration 2032087) in Carlsbad, CA, United States. It lists 11 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 29, 2019. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2032087
FEI number: 3003355251
Address: 2042 Corte Del Nogal, Carlsbad, CA, United States, 92011
Owner or operator: QUALIGEN, INC. (9040045)
Roles: Complaint file establishment, Manufacturer
First device listed: May 18, 2000
Registered through: 2026
Brand names listed: FAST PACK (TM) ANALYZER SYSTEM, FAST PACK TSH IMMUNOASSAY, FastPack Free T4 Immunoassay, FastPack PSA Controls, FastPack PSA Verifier, FastPack TPSA Calibrator, FastPack TPSA Immunoassay, FastPack TSH Immunoassay and more

Devices it lists

Device	Product code	Class	Role	Source
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Free Thyroxine	CEC	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 29, 2019	K182521	FastPack IP Sex Hormone Binding Globulin Immunoassay	CDZ	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
July 3, 2013	K123983	FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS	MRG	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
March 8, 2013	K123725	FASTPACK CONTROL KIT	JJY	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
February 18, 2011	K101388	FASTPACK TESTO IMMUNOASSAY	CDZ	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
August 13, 2010	K101390	FASTPACK TSH IMMUNOASSAY	JLW	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
December 6, 2007	K072264	FASTPACK HCG IMMUNOASSAY	JHI	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
April 2, 2007	K062957	FASTPACK TOTAL PSA METHOD VERIFICATION KIT	JJX	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
January 4, 2006	K052301	FASTPACK TSH IMMUNOASSAY	JLW	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
July 3, 2003	K030329	FASTPACK FREE T4 IMMUNOASSAY	CEC	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
September 30, 2002	K022533	FASTPACK TESTOSTERONE CALIBRATOR	JIT	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
November 30, 2000	K003096	FASTPACK CALIBRATORS	JIT	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
November 29, 2000	K003095	FASTPACK CONTROL	JJX	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov
October 25, 2000	K003094	FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER	LTJ	Substantially Equivalent	Qualigen, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 3, 2024	95807	Class III	Ongoing	The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.	Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due	accessdata.fda.gov
August 26, 2024	95326	Class II	Ongoing	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer	Thyroid Stimulating Hormone (TSH) calibrator card has an incorrect barcode linked to incorrect information, that may allow successful system calibration, but the TSH results obtained could be higher than expected.	accessdata.fda.gov
November 6, 2019	85134	Class II	Terminated	The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human seru	The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.	accessdata.fda.gov
July 7, 2017	77726	Class II	Terminated	Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit	Specific lots have been reported to produce falsely lower than expected results for Vitamin D	accessdata.fda.gov
November 8, 2013	66842	Class II	Terminated	FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-speci	Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.	accessdata.fda.gov
September 29, 2008	50115	Not yet classified	Terminated	FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the mana	The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.	accessdata.fda.gov
September 19, 2003	27562	Not yet classified	Terminated	Device to determine quantitative total testosterone in human serum	Kits may produce results that are falsely elevated.	accessdata.fda.gov

Compare with other makers

Updated January 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.