Cleared Traditional

125I QUICK-MB TEST KIT FOR QUANTITATION (K821964) - FDA 510(k) Clearance

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

K821964 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Jul 1982
Decision
21d
Days
Class 2
Risk

K821964 is an FDA 510(k) clearance for the 125I QUICK-MB TEST KIT FOR QUANTITATION. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry 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 Intl. Immunoassay Laboratories, Inc. devices

Submission Details

510(k) Number K821964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1982
Decision Date July 22, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHT Chromatographic Separation, Cpk Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHT Chromatographic Separation, Cpk Isoenzymes

All 20
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K821964.
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359 · Helena Laboratories · Apr 1993
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · Helena Laboratories · Feb 1990
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · Helena Laboratories · Nov 1982
CK-MB
K771497 · Boehringer Mannheim Corp. · Aug 1977