Cleared Traditional

K901122 - TECHNICON CHEM 1 CLINICAL ANALYZER URIN...

K901122 is the FDA 510(k) clearance for TECHNICON CHEM 1 CLINICAL ANALYZER URIN... by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K901122 · Technicon Instruments Corp. · Chemistry device
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Mar 1990
Decision
17d
Days
Class 2
Risk

K901122 is an FDA 510(k) clearance for the TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on March 29, 1990 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 K901122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date March 29, 1990
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K901122.
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · Heraeus Kulzer, Inc. · Dec 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · Em Diagnostic Systems, Inc. · Jul 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · King Diagnostics, Inc. · Jul 1991
COULTER GLUCOSE REAGENT
K897160 · Coulter Electronics, Inc. · Mar 1990
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600
K896028 · American Research Products Co. · Nov 1989
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · Abbott Laboratories · Oct 1989