| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | ELECSYS HBSAG TEST SYSTEM |
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| Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Applicant | ROCHE DIAGNOSTICS CORP.
9115 HAGUE ROAD
P.O. BOX 50416
INDIANAPOLIS, IN 46250-0457 |
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| PMA Number | P990012 |
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| Supplement Number | S006 |
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| Date Received | 04/30/2008 |
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| Decision Date | 10/30/2008 |
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Withdrawal Date
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05/05/2021 |
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| Product Code |
LOM |
| Advisory Committee |
Microbiology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL TO EXTEND APPLICATION OF THE ELECSYS HBSAG AND ELECSYS ANTI-HBS TEST SYSTEMS ONTO THE UPDATED VERSION OF THE MODULAR ANALYTICS E170 ANALYZER KNOWN AS THE COBAS E 601 ANALYZER. WHILE THE MODULAR ANALYTICS MODULAR SYSTEM INTEGRATES THE E170 MODULE WITH CLINICAL CHEMISTRY MODULES P OR D, THE COBAS E 601 IMMUNOASSAY ANALYZER IS A COMPONENT OF THE C6000 MODULAR SYSTEM WHICH INTEGRATES IMMUNOLOGY TESTING WITH THE COBAS C 501 CLINICAL CHEMISTRY ANALYSER. THERE HAVE BEEN NO CHANGES TO THE COMPOSITION OF ANY OF TE TEST SYSTEM REAGENTS (IMMUNOASSAY, CONTROLS OR CONFIRMATORY TEST), THE APPLICATION PARAMETERS, THE ANALYZER¿S ANALYTICAL MEASURING COMPONENT OR HOW THE RESULTS ARE CALCULATED. THE INDICATIONS FOR USE OF THE TWO TEST SYSTEMS REMAIN THE SAME. |
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