Cleared Traditional

K790295 - TEST KIT, IIF-AMA

K790295 is an FDA 510(k) clearance for TEST KIT, manufactured by Medica Corp.. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K790295 · Medica Corp. · Immunology device
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May 1979
Decision
105d
Days
Class 2
Risk

K790295 is an FDA 510(k) clearance for the TEST KIT, IIF-AMA. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Medica Corp. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1979 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 Medica Corp. devices

FDA 510(k) Submission Details - K790295

510(k) Number K790295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1979
Decision Date May 25, 1979
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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 - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 18
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K790295.
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · Kallestad Laboratories, Inc. · Apr 1981
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · Calbiochem-Behring Corp. · Apr 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · Clinical Sciences, Inc. · Feb 1980
TEST, (IVDP) MITOCHONDRIAL ANTIBODY
K760155 · Zeus Scientific, Inc. · Jul 1976