Cleared Traditional

K053612 - DRI-STAT ACID PHOSPHATASE REAGENT

K053612 is the FDA 510(k) clearance for DRI-STAT ACID PHOSPHATASE REAGENT by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code CKB) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K053612 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
120d
Days
Class 2
Risk

K053612 is an FDA 510(k) clearance for the DRI-STAT ACID PHOSPHATASE REAGENT. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on April 26, 2006 after a review of 120 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K053612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2005
Decision Date April 26, 2006
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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 16
Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K053612.
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
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