Cleared Traditional

K772157 - CREATININE, 64972

K772157 is an FDA 510(k) clearance for CREATININE, manufactured by Harleco. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K772157 · Harleco · Chemistry device
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Dec 1977
Decision
20d
Days
Class 2
Risk

K772157 is an FDA 510(k) clearance for the CREATININE, 64972. 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 December 6, 1977 after a review of 20 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

FDA 510(k) Submission Details - K772157

510(k) Number K772157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1977
Decision Date December 06, 1977
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K772157.
SERUM, CREATININE DETERMINATIONS
K781884 · Fisher Scientific Co., LLC · Dec 1978
CREATININE REAGENT SET
K781396 · Nobel Scientific Industries, Inc. · Sep 1978
ULTRACHEM CREATININE 64972, CENTRIFUCHEM
K780514 · Harleco · May 1978
CREATININE URINE APPLI.-#32308
K772107 · Harleco · Nov 1977
CREATININE
K771834 · Gamma Enterprises, Inc. · Nov 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
K771856 · Stanbio Laboratory · Nov 1977