Cleared Traditional

K896234 - COBAS READY STAT PROFILE REAGENT STRIP

K896234 is an FDA 510(k) clearance for COBAS READY STAT PROFILE REAGENT STRIP, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K896234 · Roche Diagnostic Systems, Inc. · Chemistry device
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Feb 1990
Decision
108d
Days
Class 1
Risk

K896234 is an FDA 510(k) clearance for the COBAS READY STAT PROFILE REAGENT STRIP. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K896234

510(k) Number K896234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1989
Decision Date February 16, 1990
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

CKA Device Classification - Class 1, General Controls

Product Code CKA Nadh Oxidation/nad Reduction, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 117
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K896234.
TECHNICON AXON SYSTEM REAGENT METHODS
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K901105 · Baxter Healthcare Corp · Mar 1990
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K897163 · Coulter Electronics, Inc. · Mar 1990
ALANINE AMINOTRANSFERASE (ALT)
K896001 · American Monitor Corp. · Nov 1989
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES
K892930 · Technicon Instruments Corp. · Jul 1989
ALT REAGENT (PROCEDURE NUMBER 159)
K893560 · Sigma Chemical Co. · Jul 1989