Cleared Traditional

K896170 - REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083

K896170 is an FDA 510(k) clearance for REP CK ISOFORMS KIT CAT. NO. 3081, manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K896170

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.

JHT Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K896170.
DSL CK-MB (DSL #3200)
K904721 · Diagnostic Systems Laboratories, Inc. · Dec 1990
COULTER CK-MB ISOENZYME REAGENT
K904866 · Coulter Electronics, Inc. · Dec 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
K901450 · Intl. Immunoassay Laboratories, Inc. · May 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