Cleared Traditional

K955781 - ALBUMIN

K955781 is an FDA 510(k) clearance for ALBUMIN, manufactured by Derma Media Lab., Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K955781 · Derma Media Lab., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
83d
Days
Class 2
Risk

K955781 is an FDA 510(k) clearance for the ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 83 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K955781

510(k) Number K955781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date March 13, 1996
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
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 104
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K955781.
ALBG
K981758 · Abbott Laboratories · Jun 1998
ALBG
K981468 · Abbott Laboratories · May 1998
ALB OR ALBUMIN
K971445 · Carolina Liquid Chemistries Corp. · May 1997
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