Cleared Traditional

K962247 - HICHEM CK/NAC REAGENT KIT

K962247 is an FDA 510(k) clearance for HICHEM CK/NAC REAGENT KIT, manufactured by Elan Pharma, Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K962247 · Elan Pharma, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
65d
Days
Class 2
Risk

K962247 is an FDA 510(k) clearance for the HICHEM CK/NAC REAGENT KIT. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Elan Pharma, Inc. (Brea, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Elan Pharma, Inc. devices

FDA 510(k) Submission Details - K962247

510(k) Number K962247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1996
Decision Date August 15, 1996
Days to Decision 65 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 88d · This submission: 65d
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 115
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K962247.
CREATINE KINASE (CK)
K972155 · Stanbio Laboratory · Jul 1997
CREATINE KINASE-MB REAGENT SET
K971566 · Horizon Diagnostics, Inc. · Jul 1997
CK REAGENT
K971396 · Carolina Liquid Chemistries Corp. · May 1997
CK-MB (NAC-ACT)
K951223 · Randox Laboratories, Ltd. · Dec 1995
CREATINE KINASE REAGENT SYSTEM
K952745 · Medical Diagnostic Technologies, Inc. · Aug 1995
IL TEST CK-MB
K952646 · Instrumentation Laboratory CO · Aug 1995