Cleared Traditional

K952427 - CX ALANINE

K952427 is an FDA 510(k) clearance for CX ALANINE, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K952427 · Beckman Instruments, Inc. · Chemistry device
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Sep 1995
Decision
120d
Days
Class 1
Risk

K952427 is an FDA 510(k) clearance for the CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE .... Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on September 21, 1995 after a review of 120 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K952427

510(k) Number K952427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1995
Decision Date September 21, 1995
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 102
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K952427.
DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
K061020 · Dade Behring, Inc. · May 2006
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
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ALT INCORPORATING DST
K961123 · Trace Scientific , Ltd. · Apr 1996
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
K952744 · Medical Diagnostic Technologies, Inc. · Aug 1995
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
K951332 · Dade Intl., Inc. · Jun 1995
HICHEM ALT REAGENT KIT
K951818 · Hi Chem, Inc. · May 1995