Cleared Traditional

TDX REA CREATININE (K843916) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843916 · Abbott Laboratories · Chemistry device
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Oct 1984
Decision
25d
Days
Class 2
Risk

K843916 is an FDA 510(k) clearance for the TDX REA CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 25 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

Submission Details

510(k) Number K843916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date October 30, 1984
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
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 63
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K843916.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)
K861819 · Eastman Kodak Company · Jun 1986
VISION CREATININE
K854846 · Abbott Laboratories · Jan 1986
TECHNICON CHEMI
K852565 · Technicon Instruments Corp. · Jul 1985
SYSTEMATE CREATININE 67223
K843105 · Em Diagnostic Systems, Inc. · Aug 1984
SERALYZER CREATININE REAGENT STRIPS
K820075 · Miles Laboratories, Inc. · Jan 1982
ULTRACHEM CREA ITEM #64972
K813043 · Harleco · Nov 1981