Data / Medical devices / United States / Opti Medical Systems Inc.
Opti Medical Systems Inc.: FDA-registered device maker in Roswell, GA, United States, 11 510(k) clearances
Opti Medical Systems Inc. is registered with the FDA (registration 3004102403) in Roswell, GA, United States. It lists 16 device types. The FDA files 11 510(k) clearances under its listings, the newest dated August 22, 2013. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004102403
- Address
- 235 Hembree Park Dr, Roswell, GA, United States, 30076
- Owner or operator
- IDEXX LABORATORIES INC. (9097732)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 14, 2004
- Registered through
- 2026
- Brand names listed
- CCA-TS B-Lac Cassette, Comfort Sampler, Comfort Sampler Kit, OPTI CCA, OPTI CCA Analyzer, OPTI CCA-TS, OPTI CCA-TS Analyzer, OPTI CCA-TS B-Lac 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 |
|---|---|---|---|---|---|---|
| August 22, 2013 | K131126 | OPTI CCA-TS2 | CHL | Substantially Equivalent | Opti Medical Systems, Inc. | accessdata.fda.gov |
| January 7, 2011 | K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | CHL | Substantially Equivalent | Opti Medical Systems, Inc. | accessdata.fda.gov |
| August 13, 2007 | K070371 | FINGERTIP PULSE OXIMETER MD300C | DQA | Substantially Equivalent | Beijing Choice Electronic Technololgy Co., Ltd. | accessdata.fda.gov |
| August 4, 2006 | K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | CEM | Substantially Equivalent | Osmetech, Inc. | accessdata.fda.gov |
| September 29, 2005 | K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 | CGZ | Substantially Equivalent | Osmetech, Inc. | accessdata.fda.gov |
| June 19, 2000 | K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | JJY | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| December 16, 1999 | K993837 | AVL OPTI CRITICAL CARE ANALYZER | CGA | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| December 11, 1998 | K984299 | AVL OPTI CRITICAL CARE ANALYZER | JFP | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| February 24, 1998 | K974784 | AVL OPTI CRITICAL CARE ANALYZER | CEM | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| January 22, 1998 | K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | JJY | Substantially Equivalent | Avl Scientific Corp. | accessdata.fda.gov |
| March 24, 1988 | K880710 | PROTEIN BASE ISE CONTROL | JJR | Substantially Equivalent | Bionostics, 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 |
|---|---|---|---|---|---|---|
| June 25, 2021 | 88344 | Class II | Ongoing | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 | The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix. | accessdata.fda.gov |
| August 9, 2013 | 66105 | Class II | Terminated | Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chlor | OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures. | accessdata.fda.gov |
| July 3, 2012 | 62606 | Class II | Terminated | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters). | accessdata.fda.gov |
| March 15, 2011 | 58272 | Not yet classified | Terminated | OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium pot | The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma. | accessdata.fda.gov |
| April 20, 2009 | 54512 | Not yet classified | Terminated | OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. | Outer box labeling shows an incorrect storage temperature range. | accessdata.fda.gov |
| May 8, 2008 | 48435 | Not yet classified | Terminated | Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app. 200l, Heparinized: 6 IU Na & 9 IU Li/100 l | This lot of Heparinized Capillary Tubes contain contaminated lithium heparin. | accessdata.fda.gov |
| July 18, 2007 | 44880 | Not yet classified | Terminated | OPTI LION E-Plus Cassettes, Model BP7507, (25 per box), In Vitro Diagnostic, OPTI Medical Systems, Inc., Roswell, Georgia 30076 | Incorrect results/stability failure; Actual device stability studies show sodium and chloride sensors age differently than anticipated when stored at the high end of labeled storage, therefore subsequent measurements give results outside the allowed error allowance before the 6 month expiration date shown on the device. | accessdata.fda.gov |
| June 22, 2004 | 29393 | Not yet classified | Terminated | Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIE-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box. | In some cases patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as 'Low'. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Electrode, Ion Specific, Potassium
- All makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- All makers of Oximeter To Measure Hemoglobin
- All makers of Multi-Analyte Controls, All Kinds (Assayed)
- All makers of System, Hemoglobin, Automated
Updated August 22, 2013. 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.