Cleared Traditional

K901450 - MODIFIED LABEL FOR EMBRIA-CK

K901450 is the FDA 510(k) clearance for MODIFIED LABEL FOR EMBRIA-CK by Intl. Immunoassay Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHT) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K901450 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
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May 1990
Decision
48d
Days
Class 2
Risk

K901450 is an FDA 510(k) clearance for the MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 48 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 K901450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1990
Decision Date May 15, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 12
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K901450.
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359 · Helena Laboratories · Apr 1993
DSL CK-MB (DSL #3200)
K904721 · Diagnostic Systems Laboratories, Inc. · Dec 1990
COULTER CK-MB ISOENZYME REAGENT
K904866 · Coulter Electronics, Inc. · Dec 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · Helena Laboratories · Feb 1990
CREATINE KINASE (CK) ISOENZYME MB
K881168 · Data Medical Associates, Inc. · Nov 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
K874284 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1988