Cleared Traditional

COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA (K912940) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912940 · Diagnostic Products Corp. · Immunology device
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Jul 1991
Decision
19d
Days
Class 2
Risk

K912940 is an FDA 510(k) clearance for the COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K912940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1991
Decision Date July 24, 1991
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 104d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 - JZG System, Test, Beta-2-microglobulin Immunological

All 52
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K912940.
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
K063272 · Dade Behring, Inc. · Jan 2007
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · Boehringer Mannheim Corp. · Oct 1998
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993
MILENIA BETA-2 MICROGLOBULIN
K910052 · Diagnostic Products Corp. · Mar 1991