Cleared Traditional

K884734 - CREATININE TEST (CREA) ITEM #65663

K884734 is the FDA 510(k) clearance for CREATININE TEST (CREA) ITEM #65663 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K884734 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1988
Decision
35d
Days
Class 2
Risk

K884734 is an FDA 510(k) clearance for the CREATININE TEST (CREA) ITEM #65663. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 19, 1988 after a review of 35 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K884734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date December 19, 1988
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K884734.
CREATININE 340 (ENZYMATIC)
K895847 · Sclavo, Inc. · Oct 1989
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · Em Diagnostic Systems, Inc. · Oct 1989
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · Hichem Diagnostics · May 1989
BIOTROL CREATININE H.P. REAGENT
K881856 · Biotrol, USA, Inc. · Jun 1988
CREATININE FOR CONTINUOUS FLOW INSTRUMENTS
K881400 · Catachem, Inc. · Apr 1988
CREATININE
K880629 · Tech-Co, Inc. · Mar 1988