Cleared Traditional

ANTI-GBM ANTIBODIES QUANTITATIVE KIT (K904181) - FDA 510(k) Clearance

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

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

Submission Details

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
260d slower than avg
Panel avg: 104d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.