Cleared Traditional

K834616 - AMNIO STAT-FLM AGGLUTINATION TEST (FDA 510(k) Clearance)

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

K834616 · Hana Biologics, Inc. · Microbiology device
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May 1984
Decision
163d
Days
Class 2
Risk

K834616 is an FDA 510(k) clearance for the AMNIO STAT-FLM AGGLUTINATION TEST. Classified as Chromatographic Separation, Lecithin/sphingomyelin Ratio (product code JHG), Class II - Special Controls.

Submitted by Hana Biologics, Inc. (Walker, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 163 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1455 - 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.

View all Hana Biologics, Inc. devices

Submission Details

510(k) Number K834616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date May 25, 1984
Days to Decision 163 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 102d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHG Chromatographic Separation, Lecithin/sphingomyelin Ratio
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1455
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.