Cleared Traditional

K903508 - LABELLING CHANGES TO IMPRES-MB-X

K903508 is the FDA 510(k) clearance for LABELLING CHANGES TO IMPRES-MB-X by Intl. Immunoassay Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHW) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K903508 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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Sep 1990
Decision
38d
Days
Class 2
Risk

K903508 is an FDA 510(k) clearance for the LABELLING CHANGES TO IMPRES-MB-X. 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 September 7, 1990 after a review of 38 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 K903508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date September 07, 1990
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K903508.
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
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K822897 · Diagnostic Systems Laboratories, Inc. · Dec 1982
CARDIOZYME PLUS CK-MB ITEM #65045
K811573 · Harleco · Jun 1981
CARDIOZYME PLUS CK-MB ITEM #65045 (G)
K811575 · Harleco · Jun 1981