Cleared Traditional

ALBUMIN REAGENT SET (K855158) - FDA 510(k) Clearance

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

K855158 · Technostics Intl. · Chemistry device
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Jan 1986
Decision
19d
Days
Class 2
Risk

K855158 is an FDA 510(k) clearance for the ALBUMIN REAGENT SET. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 19 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 Technostics Intl. devices

Submission Details

510(k) Number K855158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K855158.
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · Em Diagnostic Systems, Inc. · Oct 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · Em Diagnostic Systems, Inc. · Dec 1986
ALBUMIN (BCG) REAGENT
K861467 · Sigma Diagnostics, Inc. · May 1986
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · Technicon Instruments Corp. · Apr 1985
SYSTEMATE ALBUMIN
K843108 · Em Diagnostic Systems, Inc. · Aug 1984