Cleared Traditional

K981240 - CREATININE (CREA)

K981240 is an FDA 510(k) clearance for CREATININE (CREA), manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K981240 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
53d
Days
Class 2
Risk

K981240 is an FDA 510(k) clearance for the CREATININE (CREA). Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 29, 1998 after a review of 53 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K981240

510(k) Number K981240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date May 29, 1998
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K981240.
VITROS CHEMISTRY PRODUCTS CREA DT SLIDES
K001769 · Ortho-Clinical Diagnostics · Jun 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd. · Feb 2000
CREA
K981799 · Abbott Laboratories · Jul 1998
RANDOX CREATININE
K973993 · Randox Laboratories, Ltd. · Mar 1998
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · Sigma Diagnostics, Inc. · Sep 1997
SIGMA DIAGNOSTICS CREATININE REAGENT KIT
K963534 · Sigma Diagnostics, Inc. · Sep 1996