Cleared Traditional

K972333 - AMMONIA/IRON STANDARD KIT

K972333 is an FDA 510(k) clearance for AMMONIA/IRON STANDARD KIT, manufactured by Verichem Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K972333 · Verichem Laboratories, Inc. · Chemistry device
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Jul 1997
Decision
30d
Days
Class 2
Risk

K972333 is an FDA 510(k) clearance for the AMMONIA/IRON STANDARD KIT. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Verichem Laboratories, Inc. (Providence, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 30 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

FDA 510(k) Submission Details - K972333

510(k) Number K972333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1997
Decision Date July 23, 1997
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
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 - JIX Calibrator, Multi-analyte Mixture

All 269
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K972333.
BECKMAN CALIBRATOR 2 (CAL2)
K973932 · Beckman Instruments, Inc. · Dec 1997
BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
K973928 · Beckman Instruments, Inc. · Dec 1997
MATRIX PLUS MULTI-CALIBRATOR KIT
K973345 · Verichem Laboratories, Inc. · Oct 1997
SYNCHRON SYSTEMS CAL 5 PLUS
K971283 · Beckman Instruments, Inc. · Jun 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD
K971333 · Beckman Instruments, Inc. · May 1997
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
K970921 · Alko Diagnostic Corp. · Apr 1997