Cleared Traditional

K863078 - CREATININE-E

K863078 is the FDA 510(k) clearance for CREATININE-E by J. D. Assoc.. It is a Class 2 Chemistry device (product code JFY) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K863078 · J. D. Assoc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
28d
Days
Class 2
Risk

K863078 is an FDA 510(k) clearance for the CREATININE-E. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 28 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 J. D. Assoc. devices

Submission Details

510(k) Number K863078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date September 09, 1986
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFY Enzymatic Method, 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 - JFY Enzymatic Method, Creatinine

All 31
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K863078.
REFLOTRON CREATININE TEST TABS
K903573 · Boehringer Mannheim Corp. · Sep 1990
KODAK EKTACHEM DT SLIDES (CRSC)
K875191 · Eastman Kodak Company · Feb 1988
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
K864992 · Reagents Applications, Inc. · Feb 1987
CREATININE PAP
K854766 · Boehringer Mannheim Corp. · Jan 1986
CREATININE REAGENT SET
K841070 · Medical Specialties, Inc. · May 1984
ENXYMATIC CREATININE TEST
K812095 · Boehringer Mannheim Corp. · Aug 1981