Cleared Traditional

K852392 - EDC/TITAN GELISO-TOTAL CPK ISOENZYME PR...

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

K852392 · Helena Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 99
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
ISOENZYME TEST CK-MB
K850212 · Sclavo, Inc. · Feb 1985
TITAN GEL ISO DOT CPK PROCEDURE
K842755 · Helena Laboratories · Sep 1984