Cleared Traditional

K232904 - Access Ostase

K232904 is an FDA 510(k) clearance for Access Ostase, manufactured by Beckman Coulter. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K232904 · Beckman Coulter · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
210d
Days
Class 2
Risk

K232904 is an FDA 510(k) clearance for the Access Ostase. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Beckman Coulter (Chaska, US). The FDA issued a Cleared decision on April 15, 2024 after a review of 210 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 devices

FDA 510(k) Submission Details - K232904

510(k) Number K232904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2023
Decision Date April 15, 2024
Days to Decision 210 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
122d slower than avg
Panel avg: 88d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIN Device Classification - Class 2, Special Controls

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 20
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K232904.
IDS-iSYS Ostase BAP
K200475 · Immunodiagnostic Systems , Ltd. · Sep 2020
SPIFE 2000/3000 ALP 40, 20
K020625 · Helena Laboratories · May 2002
HYDRAGEL ISO-PAL K20 (PN 3022)
K011113 · Sebia · Jun 2001
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · Beckman Coulter, Inc. · Mar 2000
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · Hybritech, Inc. · Sep 1997
OPUS BONE ALP
K964764 · Behring Diagnostics, Inc. · Jan 1997