Cleared Traditional

K971445 - ALB OR ALBUMIN

K971445 is an FDA 510(k) clearance for ALB OR ALBUMIN, manufactured by Carolina Liquid Chemistries Corp.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K971445 · Carolina Liquid Chemistries Corp. · Chemistry device
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May 1997
Decision
11d
Days
Class 2
Risk

K971445 is an FDA 510(k) clearance for the ALB OR ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 11 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 Carolina Liquid Chemistries Corp. devices

FDA 510(k) Submission Details - K971445

510(k) Number K971445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1997
Decision Date May 02, 1997
Days to Decision 11 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
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green 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 - CIX Bromcresol Green Dye-binding, Albumin

All 100
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K971445.
RANDOX ALBUMIN
K984494 · Randox Laboratories, Ltd. · Mar 1999
ALBG
K981758 · Abbott Laboratories · Jun 1998
ALBG
K981468 · Abbott Laboratories · May 1998
TRACE COBAS MIRA RANGE
K952488 · Trace Scientific , Ltd. · Oct 1995
DMA ALBUMIN PROCEDURE
K946355 · Data Medical Associates, Inc. · Mar 1995
ALBUMIN QVET
K943000 · Prisma Systems · Dec 1994