Cleared Traditional

K902543 - ACID PHOSPHOTASE REAGENT TEST AND KIT

K902543 is an FDA 510(k) clearance for ACID PHOSPHOTASE REAGENT TEST AND KIT, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CKB cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K902543 · Crestat Diagnostics, Inc. · Chemistry device
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Sep 1990
Decision
93d
Days
Class 2
Risk

K902543 is an FDA 510(k) clearance for the ACID PHOSPHOTASE REAGENT TEST AND KIT. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Portland, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 93 days - within the typical 510(k) review window.

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 Crestat Diagnostics, Inc. devices

FDA 510(k) Submission Details - K902543

510(k) Number K902543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1990
Decision Date September 07, 1990
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
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 K902543.
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)
K974695 · Roche Diagnostic Systems, Inc. · May 1998
OLYMPUS ACID PHOSPHATASE REAGENT
K963640 · Olympus America, Inc. · Feb 1997
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
ACP KINETIC TEST (ACID PHOSPHATASE TEST)
K881204 · Sclavo, Inc. · Apr 1988