Opti Medical Systems Inc
Roswell, GA, US
OPTI MEDICAL SYSTEMS INC. appears in FDA device records in Roswell, GA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Opti Medical Systems Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Osmetech, Inc.510(k), recall
510(k) clearance history
FDA records hold 7 510(k) clearances for Opti Medical Systems Inc between 2001 and 2021. The busiest year on record is 2001, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200986 | OPTI® B-Lac Cassette | CHL | Substantially Equivalent | |
| K131126 | OPTI CCA-TS2 | CHL | Substantially Equivalent | |
| K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | CHL | Substantially Equivalent | |
| K061730 | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 | CEM | Substantially Equivalent | |
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 | CGZ | Substantially Equivalent | |
| K023677 | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | LIB | Substantially Equivalent | |
| K011043 | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) | JXA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004102403 | 3004102403 | OPTI MEDICAL SYSTEMS INC. | 235 Hembree Park Dr, ROSWELL, GA 30076 US | 2026 | and 6 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CBTArterial Blood Sampling Kit
- LIBDevice, General Purpose, Microbiology, Diagnostic
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CDSElectrode, Ion Specific, Urea Nitrogen
- CGZElectrode, Ion-Specific, Chloride
- JJRElectrolyte Controls (Assayed And Unassayed)
- CGAGlucose Oxidase, Glucose
- JXAKit, Screening, Urine
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DQAOximeter
- GLYOximeter To Measure Hemoglobin
- GKRSystem, Hemoglobin, Automated
- GIOTube, Collection, Capillary Blood
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2310-2021 | 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. | Class II | Open, Classified | |
| Z-0029-2014 | 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, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma. | 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. | Class II | Terminated | |
| Z-2440-2012 | 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 oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer. | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters). | Class II | Terminated | |
| Z-2558-2011 | 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 potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer. | 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. | Terminated | ||
| Z-1083-2010 | 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. | Terminated | ||
| Z-2152-2008 | 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. | Terminated | ||
| Z-0119-2008 | 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. | Terminated | ||
| Z-1064-04 | 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'. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain