Cleared Traditional

K963640 - OLYMPUS ACID PHOSPHATASE REAGENT

K963640 is the FDA 510(k) clearance for OLYMPUS ACID PHOSPHATASE REAGENT by Olympus America, Inc.. It is a Class 2 Chemistry device (product code CKB) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K963640 · Olympus America, Inc. · Chemistry device
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Feb 1997
Decision
159d
Days
Class 2
Risk

K963640 is an FDA 510(k) clearance for the OLYMPUS ACID PHOSPHATASE REAGENT. 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 February 18, 1997 after a review of 159 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1020 - 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 Olympus America, Inc. devices

Submission Details

510(k) Number K963640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date February 18, 1997
Days to Decision 159 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 88d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 17
Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K963640.
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
K023840 · Bayer Diagnostics Corp. · Jan 2003
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER
K981743 · Olympus America, Inc. · Jun 1998
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 REAGENT
K892393 · Medical Analysis Systems, Inc. · Jul 1989
TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)
K884747 · Technicon Instruments Corp. · Jan 1989