Cleared Traditional

K935828 - HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)

K935828 is an FDA 510(k) clearance for HEMAGEN ENA SCREEN-6 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 134-day FDA review.

K935828 · Hemagen Diagnostics, Inc. · Immunology device
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Apr 1994
Decision
134d
Days
Class 2
Risk

K935828 is an FDA 510(k) clearance for the HEMAGEN ENA SCREEN-6 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 20, 1994 after a review of 134 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 - K935828

510(k) Number K935828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date April 20, 1994
Days to Decision 134 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
29d slower than avg
Panel avg: 105d · This submission: 134d
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 K935828.
ANA SCREEN ELISA TEST SYSTEM
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K940229 · Elias U.S.A., Inc. · May 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · Elias U.S.A., Inc. · May 1994
RELISA ENA ANTIBODY SCREENING TEST SYSTEM
K935129 · Immuno Concepts, Inc. · Jan 1994
QUANTA LITE(TM) HISTONE ELISA
K934053 · Inova Diagnostics, Inc. · Dec 1993
DIASTAT ANTI-CENTROMERE KIT
K932877 · Shield Diagnostics, Ltd. · Oct 1993