Cleared Traditional

K132664 - ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR

K132664 is an FDA 510(k) clearance for ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CJW cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K132664 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Oct 2013
Decision
50d
Days
Class 2
Risk

K132664 is an FDA 510(k) clearance for the ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIB.... Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 16, 2013 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K132664

510(k) Number K132664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2013
Decision Date October 16, 2013
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJW Device Classification - Class 2, Special Controls

Product Code CJW Bromcresol Purple Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CJW Bromcresol Purple Dye-binding, Albumin

All 17
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K132664.
Albumin BCP2
K203530 · Abbott Ireland Diagnostics Division · Mar 2022
Albumin BCP
K193001 · SENTINEL CH. SpA · Dec 2019
ALBUMIN REAGENT
K021636 · Intersect Systems, Inc. · Jul 2002
RANDOX ALBUMIN
K000483 · Randox Laboratories, Ltd. · Mar 2000
ALBUMIN BCG, MODEL AL 103-01
K990978 · A.P. Total Care, Inc. · May 1999
ALBP
K981814 · Abbott Laboratories · Jul 1998