Cleared Traditional

K053612 - DRI-STAT ACID PHOSPHATASE REAGENT

K053612 is an FDA 510(k) clearance for DRI-STAT ACID PHOSPHATASE REAGENT, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K053612

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.

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 K053612.
ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
K023840 · Bayer Diagnostics Corp. · Jan 2003
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
OLYMPUS ACID PHOSPHATASE REAGENT
K963640 · Olympus America, Inc. · Feb 1997
IL TEST ACID PHOSPHATASE
K943366 · Instrumentation Laboratory CO · Jan 1996