Data / Medical devices / United States / Quidel Cardiovascular Inc.
Quidel Cardiovascular Inc.: FDA-registered device maker in San Diego, CA, United States, 9 510(k) clearances
Quidel Cardiovascular Inc. is registered with the FDA (registration 3013982035) in San Diego, CA, United States. It lists 20 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 19, 2019. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013982035
- Address
- 9975 Summers Ridge Road --, San Diego, CA, United States, 92121
- Owner or operator
- QuidelOrtho Corporation (2024674)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- October 16, 2017
- Registered through
- 2026
- Brand names listed
- Quidel Triage NT-proBNP Test, Quidel Triage TOX Drug Screen, 94600, Quidel Triage TOX Drug Screen, 94600 Control 1, Quidel Triage TOX Drug Screen, 94600 Control 2, Quidel Triage(R) BNP Calibration Verification, Quidel Triage(R) BNP Control 1, Quidel Triage(R) BNP Control 2, Quidel Triage(R) BNP Test and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 19, 2019 | K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | DKZ | Substantially Equivalent | Quidel Cardiovascular, Inc. | accessdata.fda.gov |
| December 7, 2007 | K072892 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5 | JJY | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| September 22, 2005 | K051787 | TRIAGE BNP TEST, MODEL 98000XR | NBC | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| November 29, 2004 | K042890 | TRIAGE D-DIMER TEST, MODEL 98100 | GHH | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| February 21, 2003 | K030286 | TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL | NBC | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| July 1, 2002 | K021317 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | NBC | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| March 2, 2000 | K000231 | TRIAGE BNP CALIBRATION VERIFICATION CONTROLS | JJX | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| February 29, 2000 | K000230 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS | JJX | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
| January 13, 1998 | K973547 | TRIAGE STATMETER | KHO | Substantially Equivalent | Biosite Incorporated | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 25, 2023 | 92447 | Class I | Ongoing | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045. | Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis | accessdata.fda.gov |
| April 9, 2019 | 84698 | Class II | Terminated | Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail. | accessdata.fda.gov |
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Updated July 7, 2023. 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.