Cleared Traditional

K930359 - CARDIO REP-CAT. NO. 1400 & CK ISOFORMS ...

K930359 is the FDA 510(k) clearance for CARDIO REP-CAT. NO. 1400 & CK ISOFORMS ... by Helena Laboratories. It is a Class 2 Chemistry device (product code JHT) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K930359 · Helena Laboratories · Chemistry device
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Apr 1993
Decision
76d
Days
Class 2
Risk

K930359 is an FDA 510(k) clearance for the CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 12, 1993 after a review of 76 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 Helena Laboratories devices

Submission Details

510(k) Number K930359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date April 12, 1993
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
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 11
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K930359.
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
K991299 · Princeton BioMeditech Corp. · May 1999
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