Cleared Traditional

K914888 - TECHNICON CHEM 1(TM) SYST (GEN2 SYST)

K914888 is the FDA 510(k) clearance for TECHNICON CHEM 1(TM) SYST (GEN2 SYST) by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K914888 · Technicon Instruments Corp. · Chemistry device
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Nov 1991
Decision
28d
Days
Class 2
Risk

K914888 is an FDA 510(k) clearance for the TECHNICON CHEM 1(TM) SYST (GEN2 SYST). Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 27, 1991 after a review of 28 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K914888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1991
Decision Date November 27, 1991
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 76
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K914888.
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ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920 · Em Diagnostic Systems, Inc. · Sep 1991
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K913195 · Eastman Kodak Company · Aug 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
K905660 · Em Diagnostic Systems, Inc. · Jan 1991