Cleared Traditional

TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K971989) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971989 · Bayer Corp. · Microbiology device
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Oct 1997
Decision
146d
Days
Class 2
Risk

K971989 is an FDA 510(k) clearance for the TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM). Classified as Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (product code LGD), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 22, 1997 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3780 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K971989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1997
Decision Date October 22, 1997
Days to Decision 146 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 102d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

All 105
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