Cleared Traditional

K895847 - CREATININE 340 (ENZYMATIC)

K895847 is the FDA 510(k) clearance for CREATININE 340 (ENZYMATIC) by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K895847 · Sclavo, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
27d
Days
Class 2
Risk

K895847 is an FDA 510(k) clearance for the CREATININE 340 (ENZYMATIC). Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 27 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 Sclavo, Inc. devices

Submission Details

510(k) Number K895847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date October 30, 1989
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K895847.
CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY
K901298 · Olympus Corp. · Apr 1990
AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791
K900666 · American Research Products Co. · Apr 1990
AMRESCO CREATININE REAGENT #4316100
K896686 · American Research Products Co. · Feb 1990
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · Em Diagnostic Systems, Inc. · Oct 1989
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · Hichem Diagnostics · May 1989
CREATININE TEST (CREA) ITEM #65663
K884734 · Em Diagnostic Systems, Inc. · Dec 1988