Cleared Traditional

K896170 - REP CK ISOFORMS KIT CAT. NO. 3081

K896170 is the FDA 510(k) clearance for REP CK ISOFORMS KIT CAT. NO. 3081 by Helena Laboratories. It is a Class 2 Chemistry device (product code JHT) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K896170 · Helena Laboratories · Chemistry device
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Feb 1990
Decision
114d
Days
Class 2
Risk

K896170 is an FDA 510(k) clearance for the REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083. 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 February 16, 1990 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K896170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date February 16, 1990
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 88d · This submission: 114d
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 K896170.
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
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
COULTER DART CK-MB ISOENZYME REAGENT SYSTEM
K872041 · Coulter Electronics, Inc. · Sep 1987