Cleared Traditional

SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181) - FDA 510(k) Clearance

Class I Chemistry device.

K883181 · Beckman Instruments, Inc. · Chemistry device
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Sep 1988
Decision
54d
Days
Class 1
Risk

K883181 is an FDA 510(k) clearance for the SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE. 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 19, 1988 after a review of 54 days - a notably fast clearance cycle.

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: 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K883181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1988
Decision Date September 19, 1988
Days to Decision 54 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
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 42
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K883181.
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · Abbott Laboratories · Apr 1989
CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN
K885144 · Heraeus Kulzer, Inc. · Feb 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
K884376 · Em Diagnostic Systems, Inc. · Jan 1989
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · Miles Laboratories, Inc. · Apr 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · Em Diagnostic Systems, Inc. · Jan 1988
PYRIDOXAL-5-PHOSPHATE TABLETS
K874835 · Boehringer Mannheim Corp. · Jan 1988