Cleared Traditional

K913025 - ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16

K913025 is an FDA 510(k) clearance for ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CJW cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K913025 · Em Diagnostic Systems, Inc. · Chemistry device
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Oct 1991
Decision
92d
Days
Class 2
Risk

K913025 is an FDA 510(k) clearance for the ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on October 9, 1991 after a review of 92 days - within the typical 510(k) review window.

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: 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K913025

510(k) Number K913025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1991
Decision Date October 09, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 K913025.
ALBUMIN BCG, MODEL AL 103-01
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ALBP
K981814 · Abbott Laboratories · Jul 1998
ALBP
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ALBUMIN REAGENT SET
K905776 · Biochemical Trade, Inc. · Feb 1991
ALBUMIN (BCP)
K863226 · Sigma Diagnostics, Inc. · Sep 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · Em Diagnostic Systems, Inc. · Sep 1986