Cleared Traditional

K990978 - ALBUMIN BCG, MODEL AL 103-01

K990978 is an FDA 510(k) clearance for ALBUMIN BCG, manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code CJW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990978 · A.P. Total Care, Inc. · Chemistry device
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May 1999
Decision
63d
Days
Class 2
Risk

K990978 is an FDA 510(k) clearance for the ALBUMIN BCG, MODEL AL 103-01. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on May 25, 1999 after a review of 63 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K990978

510(k) Number K990978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1999
Decision Date May 25, 1999
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 16
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K990978.
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
ALBUMIN REAGENT
K021636 · Intersect Systems, Inc. · Jul 2002
RANDOX ALBUMIN
K000483 · Randox Laboratories, Ltd. · Mar 2000
ALBP
K981814 · Abbott Laboratories · Jul 1998
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · Em Diagnostic Systems, Inc. · Oct 1991
ALBUMIN REAGENT SET
K905776 · Biochemical Trade, Inc. · Feb 1991