Cleared Traditional

K780514 - ULTRACHEM CREATININE 64972

K780514 is the FDA 510(k) clearance for ULTRACHEM CREATININE 64972 by Harleco. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K780514 · Harleco · Chemistry device
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May 1978
Decision
50d
Days
Class 2
Risk

K780514 is an FDA 510(k) clearance for the ULTRACHEM CREATININE 64972, CENTRIFUCHEM. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 K780514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1978
Decision Date May 19, 1978
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 111
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K780514.
REAGENT KIT, BAKERS DIAGNOSTIC
K790044 · J.T. Baker Chemical Co. · Feb 1979
HILAR
K782094 · Hi Chem, Inc. · Jan 1979
SERUM, CREATININE DETERMINATIONS
K781884 · Fisher Scientific Co., LLC · Dec 1978
CREATININE, 64972
K772157 · Harleco · Dec 1977
CREATININE URINE APPLI.-#32308
K772107 · Harleco · Nov 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
K771856 · Stanbio Laboratory · Nov 1977