Cleared Traditional

K943366 - IL TEST ACID PHOSPHATASE

K943366 is the FDA 510(k) clearance for IL TEST ACID PHOSPHATASE by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CKB) cleared through the Traditional 510(k) pathway after a 565-day FDA review.

K943366 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
565d
Days
Class 2
Risk

K943366 is an FDA 510(k) clearance for the IL TEST ACID PHOSPHATASE. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 29, 1996 after a review of 565 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K943366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1994
Decision Date January 29, 1996
Days to Decision 565 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
477d slower than avg
Panel avg: 88d · This submission: 565d
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 14
Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K943366.
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
OLYMPUS ACID PHOSPHATASE REAGENT
K963640 · Olympus America, Inc. · Feb 1997
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