Cleared Traditional

K901113 - MATRIX PLUS(TM) CHEMISTRY REFERENCE STA...

K901113 is the FDA 510(k) clearance for MATRIX PLUS(TM) CHEMISTRY REFERENCE STA... by Verichem Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K901113 · Verichem Laboratories, Inc. · Chemistry device
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Mar 1990
Decision
22d
Days
Class 2
Risk

K901113 is an FDA 510(k) clearance for the MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Verichem Laboratories, Inc. (East Providence, US). The FDA issued a Cleared decision on March 29, 1990 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Verichem Laboratories, Inc. devices

Submission Details

510(k) Number K901113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date March 29, 1990
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 87
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K901113.
BIOTROL PROTEIN MULTILEVEL STANDARDS
K910721 · Biotrol, USA, Inc. · May 1991
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K905820 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477 · Em Diagnostic Systems, Inc. · Feb 1991
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · Reagents Applications, Inc. · Aug 1988
TERUMO SENSIBEAD EIA PROGESTERONE KIT
K881693 · Terumo Medical Corp. · Jun 1988
CALCIUM CALIBRATOR
K872051 · Wako Chemicals USA, Inc. · Sep 1987