Cleared Traditional

K915420 - HEMAGEN ENA [JO-1] KIT (EIA METHOD)

K915420 is an FDA 510(k) clearance for HEMAGEN ENA [JO-1] KIT (EIA METHOD), manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K915420 · Hemagen Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
127d
Days
Class 2
Risk

K915420 is an FDA 510(k) clearance for the HEMAGEN ENA [JO-1] 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 April 7, 1992 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Hemagen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K915420

510(k) Number K915420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date April 07, 1992
Days to Decision 127 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
22d slower than avg
Panel avg: 105d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K915420.
QUANTA LITE SM ELISA
K922831 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE SS-B ELISA
K922832 · Inova Diagnostics, Inc. · Sep 1992
QUANTA LITE RNP ELISA
K922833 · Inova Diagnostics, Inc. · Sep 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383 · Immco Diagnostics, Inc. · Mar 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384 · Immco Diagnostics, Inc. · Mar 1992
ANTI-ENA ANTIBODY TEST (SM)
K920385 · Immco Diagnostics, Inc. · Mar 1992