Cleared Traditional

K963640 - OLYMPUS ACID PHOSPHATASE REAGENT

K963640 is an FDA 510(k) clearance for OLYMPUS ACID PHOSPHATASE REAGENT, manufactured by Olympus America, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K963640

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.

CKB Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K963640.
ACP
K991010 · Abbott Diagnostics Mfg., Inc. · May 1999
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 PHOSPHOTASE REAGENT TEST AND KIT
K902543 · Crestat Diagnostics, Inc. · Sep 1990
ACID PHOSPHATASE REAGENT
K892393 · Medical Analysis Systems, Inc. · Jul 1989