Cleared Traditional

K770819 - ULTRACHEM CREATININE

K770819 is the FDA 510(k) clearance for ULTRACHEM CREATININE by Harleco. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K770819 · Harleco · Chemistry device
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Jul 1977
Decision
68d
Days
Class 2
Risk

K770819 is an FDA 510(k) clearance for the ULTRACHEM CREATININE. 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 July 11, 1977 after a review of 68 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 K770819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1977
Decision Date July 11, 1977
Days to Decision 68 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
20d faster than avg
Panel avg: 88d · This submission: 68d
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 K770819.
MULTISTAT III CREATININE TEST
K771443 · Instrumentation Laboratory CO · Aug 1977
CREATININE ANALYSIS PRODUCTS
K771365 · Abbott Laboratories · Aug 1977
CREATININE ANALYZER 2
K771335 · Beckman Instruments, Inc. · Aug 1977
REAGENT SYSTEM
K770242 · American Monitor Corp. · Feb 1977
AUTO CREATININE REAGENT (GILFORD 3400-E)
K761280 · Harleco · Feb 1977
AUTO CREATININE REAGENT (ABBOTT SYSTEM)
K761279 · Harleco · Feb 1977