Cleared Traditional

K012474 - ATAC PAK CPK REAGENT KIT

K012474 is an FDA 510(k) clearance for ATAC PAK CPK REAGENT KIT, manufactured by Elan Holdings, Inc.. The device is a Class 2 Chemistry device with product code CGS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K012474 · Elan Holdings, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
62d
Days
Class 2
Risk

K012474 is an FDA 510(k) clearance for the ATAC PAK CPK REAGENT KIT. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on October 3, 2001 after a review of 62 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 Holdings, Inc. devices

FDA 510(k) Submission Details - K012474

510(k) Number K012474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date October 03, 2001
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 118
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