Cleared Traditional

K915234 - HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)

K915234 is the FDA 510(k) clearance for HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) by Hemagen Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K915234 · Hemagen Diagnostics, Inc. · Immunology device
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Dec 1991
Decision
28d
Days
Class 2
Risk

K915234 is an FDA 510(k) clearance for the HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD). Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K915234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date December 20, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 104d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 117
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K915234.
ANTI-ENA ANTIBODY TEST KIT
K920386 · Immco Diagnostics, Inc. · Mar 1992
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282 · Hemagen Diagnostics, Inc. · Feb 1992
HEMAGEN ENA SCREENING KIT (EIA METHOD)
K915058 · Hemagen Diagnostics, Inc. · Dec 1991
ANTI-JO-1 MICROASSAY
K911679 · Diamedix Corp. · Sep 1991
HEMAGEN ENA SCREENING KIT
K910232 · Hemagen Diagnostics, Inc. · Mar 1991
QUANTA LITE TM DSDNA
K903898 · Inova Diagnostics, Inc. · Sep 1990