Cleared Traditional

CPK-L TUBE (K781149) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K781149 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1978
Decision
34d
Days
Class 2
Risk

K781149 is an FDA 510(k) clearance for the CPK-L TUBE. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 34 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K781149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1978
Decision Date August 14, 1978
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 45
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K781149.
LIQUID-STAT LIQUID ENZYME REAGENT
K821240 · Beckman Instruments, Inc. · May 1982
SERALYZER CK REAGENT STRIPS
K820880 · Miles Laboratories, Inc. · Apr 1982
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · Sigma Chemical Co. · Dec 1978
STAC SYSTEM - ADDITIONAL ANALYTES
K772352 · Technicon Instruments Corp. · Jan 1978
MULTISTAT III CPK TEST
K771441 · Instrumentation Laboratory CO · Aug 1977