Cleared Traditional

K780100 - ULTRAZYME PLUS CK-1

K780100 is the FDA 510(k) clearance for ULTRAZYME PLUS CK-1 by Harleco. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K780100 · Harleco · Chemistry device
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Mar 1978
Decision
48d
Days
Class 2
Risk

K780100 is an FDA 510(k) clearance for the ULTRAZYME PLUS CK-1. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on March 9, 1978 after a review of 48 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 Harleco devices

Submission Details

510(k) Number K780100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1978
Decision Date March 09, 1978
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K780100.
CPK REAGENT SET, NAD REDUCTION
K781719 · Medical Analysis Systems, Inc. · Nov 1978
CPK-L TUBE
K781149 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
DIAGNOSTIC KIT, CPK
K780311 · Sclavo, Inc. · Apr 1978
CPK REAGENT SET
K780070 · Medical Analysis Systems, Inc. · Feb 1978
STAC SYSTEM - ADDITIONAL ANALYTES
K772352 · Technicon Instruments Corp. · Jan 1978
CLINICARD CK-II
K772258 · Harleco · Jan 1978