Cleared Traditional

ALBP (K981814) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981814 · Abbott Laboratories · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1998
Decision
61d
Days
Class 2
Risk

K981814 is an FDA 510(k) clearance for the ALBP. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 22, 1998 after a review of 61 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 Abbott Laboratories devices

Submission Details

510(k) Number K981814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date July 22, 1998
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K981814.
Albumin BCP
K193001 · SENTINEL CH. SpA · Dec 2019
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
RANDOX ALBUMIN
K000483 · Randox Laboratories, Ltd. · Mar 2000
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · Em Diagnostic Systems, Inc. · Oct 1991
ALBUMIN (BCP)
K863226 · Sigma Diagnostics, Inc. · Sep 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · Em Diagnostic Systems, Inc. · Sep 1986