Cleared Traditional

K844426 - ALBUMIN BCP

K844426 is an FDA 510(k) clearance for ALBUMIN BCP, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code CJW cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K844426 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
53d
Days
Class 2
Risk

K844426 is an FDA 510(k) clearance for the ALBUMIN BCP. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 7, 1985 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1035 - the FDA immunology device 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K844426

510(k) Number K844426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1984
Decision Date January 07, 1985
Days to Decision 53 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 104d · This submission: 53d
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 Immunology devices follow this clearance model.

Regulatory Peers - CJW Bromcresol Purple Dye-binding, Albumin

All 12
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K844426.
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
K863004 · Em Diagnostic Systems, Inc. · Sep 1986
VISION ALBUMIN
K862138 · Abbott Laboratories · Jun 1986
A-GENT LIQUID ALBUMIN
K860423 · Abbott Laboratories · Mar 1986
WAKO AUTOMATED REAGENTS FOR HITACHI 705
K842847 · Wako Chemicals USA, Inc. · Dec 1984
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
K830934 · Quantimetrix Corp. · Apr 1983