Cleared Traditional

K834616 - AMNIO STAT-FLM AGGLUTINATION TEST

K834616 is an FDA 510(k) clearance for AMNIO STAT-FLM AGGLUTINATION TEST, manufactured by Hana Biologics, Inc.. The device is a Class 2 Microbiology device with product code JHG cleared through the Traditional 510(k) pathway after a 163-day FDA review.

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

FDA 510(k) Submission Details - K834616

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.

JHG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - JHG Chromatographic Separation, Lecithin/sphingomyelin Ratio

Devices cleared under the same product code (JHG) and FDA review panel - the closest regulatory comparables to K834616.
AMNIOSTAT-FLM-PG
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