Cleared Traditional

K880844 - ALBUMIN REAGENT SET

K880844 is an FDA 510(k) clearance for ALBUMIN REAGENT SET, manufactured by Tech-Neal Scientific, Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K880844 · Tech-Neal Scientific, Inc. · Chemistry device
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Apr 1988
Decision
39d
Days
Class 2
Risk

K880844 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 Tech-Neal Scientific, Inc. (Westmont, US). The FDA issued a Cleared decision on April 5, 1988 after a review of 39 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 Tech-Neal Scientific, Inc. devices

FDA 510(k) Submission Details - K880844

510(k) Number K880844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1988
Decision Date April 05, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
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 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K880844.
BIOTROL ALBUMIN
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ALBUMIN TEST (ALB) ITEM #65650
K884705 · Em Diagnostic Systems, Inc. · Jan 1989
ALBUMIN CAT. # 201-03
K875207 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
WAKO(TM) AUTOKIT ALBUMIN
K880313 · Wako Chemicals USA, Inc. · Mar 1988
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · Tech-Co, Inc. · Jan 1988
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163 · Catachem, Inc. · Nov 1987