Cleared Traditional

K904181 - ANTI-GBM ANTIBODIES QUANTITATIVE KIT

K904181 is an FDA 510(k) clearance for ANTI-GBM ANTIBODIES QUANTITATIVE KIT, manufactured by Biochemical Diagnostic, Inc.. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K904181 · Biochemical Diagnostic, Inc. · Immunology device
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Sep 1991
Decision
364d
Days
Class 2
Risk

K904181 is an FDA 510(k) clearance for the ANTI-GBM ANTIBODIES QUANTITATIVE KIT. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by Biochemical Diagnostic, Inc. (Sweden, SE). The FDA issued a Cleared decision on September 10, 1991 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biochemical Diagnostic, Inc. devices

FDA 510(k) Submission Details - K904181

510(k) Number K904181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1990
Decision Date September 10, 1991
Days to Decision 364 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
259d slower than avg
Panel avg: 105d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBL Device Classification - Class 2, Special Controls

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 Immunology devices follow this clearance model.

Regulatory Peers - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 19
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K904181.
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K891099 · Immco Diagnostics, Inc. · Mar 1989