Cleared Traditional

K780311 - DIAGNOSTIC KIT

K780311 is the FDA 510(k) clearance for DIAGNOSTIC KIT by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K780311 · Sclavo, Inc. · Chemistry device
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Apr 1978
Decision
40d
Days
Class 2
Risk

K780311 is an FDA 510(k) clearance for the DIAGNOSTIC KIT, CPK. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1978 after a review of 40 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 Sclavo, Inc. devices

Submission Details

510(k) Number K780311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1978
Decision Date April 05, 1978
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 K780311.
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · Sigma Chemical Co. · Dec 1978
CPK REAGENT SET, NAD REDUCTION
K781719 · Medical Analysis Systems, Inc. · Nov 1978
CPK-L TUBE
K781149 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
ULTRAZYME PLUS CK-1
K780100 · Harleco · Mar 1978
CPK REAGENT SET
K780070 · Medical Analysis Systems, Inc. · Feb 1978
STAC SYSTEM - ADDITIONAL ANALYTES
K772352 · Technicon Instruments Corp. · Jan 1978