Cleared Special

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (K981743) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K981743 · Olympus America, Inc. · Chemistry device
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Jun 1998
Decision
22d
Days
Class 2
Risk

K981743 is an FDA 510(k) clearance for the OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on June 9, 1998 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K981743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date June 09, 1998
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code CKB Acid Phosphatase, Naphthyl Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1020
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 - CKB Acid Phosphatase, Naphthyl Phosphate

Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K981743.
DRI-STAT ACID PHOSPHATASE REAGENT
K053612 · Beckman Coulter, Inc. · Apr 2006
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
K974695 · Roche Diagnostic Systems, Inc. · May 1998
IL TEST ACID PHOSPHATASE
K943366 · Instrumentation Laboratory CO · Jan 1996
ACID PHOSPHATASE (ACP) REAGENT
K863851 · Sigma Diagnostics, Inc. · Oct 1986
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA
K823087 · Boehringer Mannheim Corp. · Nov 1982