Cleared Traditional

K912231 - PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

K912231 is an FDA 510(k) clearance for PROPOSED NEW USE OF INSTRUMENT SYSTEM A..., manufactured by Intl. Immunoassay Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K912231 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Jul 1991
Decision
49d
Days
Class 2
Risk

K912231 is an FDA 510(k) clearance for the PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 8, 1991 after a review of 49 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

FDA 510(k) Submission Details - K912231

510(k) Number K912231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date July 08, 1991
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHW Device Classification - Class 2, Special Controls

Product Code JHW U.v. Method, 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 - JHW U.v. Method, Cpk Isoenzymes

All 25
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K912231.
AXSYM CK-MB
K935924 · Abbott Laboratories · Jun 1994
CARDIO REP CK ISOENZYME KIT - 3310
K931050 · Helena Laboratories · Apr 1993
STAMBI-CK
K913349 · Intl. Immunoassay Laboratories, Inc. · Oct 1991
CREATINE KINASE UV REAGENT SET
K905588 · Biochemical Trade, Inc. · Jan 1991
LABELLING CHANGES TO IMPRES-MB-X
K903508 · Intl. Immunoassay Laboratories, Inc. · Sep 1990
ISOFOR-MM (TM)
K883222 · Intl. Immunoassay Laboratories, Inc. · Sep 1988