Cleared Traditional

K830556 - CREATININE

K830556 is the FDA 510(k) clearance for CREATININE by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830556 · Pointe Scientific, Inc., · Chemistry device
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Mar 1983
Decision
29d
Days
Class 2
Risk

K830556 is an FDA 510(k) clearance for the CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 29 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K830556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date March 24, 1983
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
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 110
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K830556.
CREATININE REAGENT SET
K832439 · Amresco, Inc. · Jan 1984
KINETIC CREATININE
K830447 · American Monitor Corp. · Mar 1983
FLOW-PAC CREATININE REAGENT SET
K830537 · Amresco, Inc. · Mar 1983
COBAS STANDARDS FOR CREATININE
K823572 · Hoffmann-La Roche, Inc. · Jan 1983
COBAS REAGENT FOR CREATININE
K823573 · Hoffmann-La Roche, Inc. · Jan 1983
LIQUIZYME CREATININE REAGENT SET
K813560 · Amresco, Inc. · Jan 1982