Cleared Traditional

K941840 - HEMAGEN ACL IGA CALIBRATOR

K941840 is the FDA 510(k) clearance for HEMAGEN ACL IGA CALIBRATOR by Hemagen Diagnostics, Inc.. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K941840 · Hemagen Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
78d
Days
Class 2
Risk

K941840 is an FDA 510(k) clearance for the HEMAGEN ACL IGA CALIBRATOR. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 K941840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date June 30, 1994
Days to Decision 78 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
26d faster than avg
Panel avg: 104d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MID System, Test, Anticardiolipin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MID System, Test, Anticardiolipin Immunological

All 45
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K941840.
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
K933786 · Immco Diagnostics, Inc. · Mar 1995
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788 · Immco Diagnostics, Inc. · Mar 1995
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · Elias U.S.A., Inc. · Sep 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288 · Elias U.S.A., Inc. · Jan 1994
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392 · Elias U.S.A., Inc. · Dec 1993
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393 · Elias U.S.A., Inc. · Dec 1993