Cleared Traditional

K822124 - TITAN GEL CPK ISOENZYME SYSTEM

K822124 is an FDA 510(k) clearance for TITAN GEL CPK ISOENZYME SYSTEM, 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 105-day FDA review.

K822124 · Helena Laboratories · Chemistry device
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Nov 1982
Decision
105d
Days
Class 2
Risk

K822124 is an FDA 510(k) clearance for the TITAN GEL CPK ISOENZYME SYSTEM. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Helena Laboratories (Walker, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 105 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 - K822124

510(k) Number K822124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1982
Decision Date November 01, 1982
Days to Decision 105 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
17d slower than avg
Panel avg: 88d · This submission: 105d
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 K822124.
MICROMI-CK(TM)
K872598 · Intl. Immunoassay Laboratories, Inc. · Aug 1987
IMACK-MB(TM)
K872592 · Intl. Immunoassay Laboratories, Inc. · Jul 1987
CK-ISOZYME U.V. REAGENT SET
K823550 · Gelman Sciences, Inc. · Jan 1983
125I QUICK-MB TEST KIT FOR QUANTITATION
K821964 · Intl. Immunoassay Laboratories, Inc. · Jul 1982
CPK CLINI GEL KIT
K791826 · Clinical Sciences, Inc. · Oct 1979
CPK-CS
K790357 · Hoffmann-La Roche, Inc. · Apr 1979