Cleared Traditional

K852392 - EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE

K852392 is an FDA 510(k) clearance for EDC/TITAN GELISO-TOTAL CPK ISOENZYME PR..., manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K852392 · Helena Laboratories · Chemistry device
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Oct 1985
Decision
139d
Days
Class 2
Risk

K852392 is an FDA 510(k) clearance for the EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 22, 1985 after a review of 139 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 - K852392

510(k) Number K852392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date October 22, 1985
Days to Decision 139 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
51d slower than avg
Panel avg: 88d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGS Device Classification - Class 2, Special Controls

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or 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 - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 117
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K852392.
CPK REAGENT SET (COLORIMETRIC)
K860096 · Sterling Diagnostics, Inc. · Feb 1986
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · Em Diagnostic Systems, Inc. · Jan 1986
CK(OPTIMIZED) REAGENT
K854501 · Sigma Diagnostics, Inc. · Dec 1985
SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205
K852483 · Em Diagnostic Systems, Inc. · Jul 1985
CK-NAC REAGENT
K852000 · Alpkem Corp. · May 1985
ISOENZYME TEST CK-MB
K850212 · Sclavo, Inc. · Feb 1985