Cleared Traditional

K831336 - SALICYLATE ASSAY KIT

K831336 is an FDA 510(k) clearance for SALICYLATE ASSAY KIT, manufactured by Quantimetrix Corp.. The device is a Class 2 Chemistry device with product code DKJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K831336 · Quantimetrix Corp. · Chemistry device
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Jul 1983
Decision
73d
Days
Class 2
Risk

K831336 is an FDA 510(k) clearance for the SALICYLATE ASSAY KIT. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Quantimetrix Corp. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3830 - 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 Quantimetrix Corp. devices

FDA 510(k) Submission Details - K831336

510(k) Number K831336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date July 07, 1983
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKJ Device Classification - Class 2, Special Controls

Product Code DKJ Colorimetry, Salicylate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3830
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 - DKJ Colorimetry, Salicylate

All 26
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K831336.
SALICYLATE TEST
K843180 · Sclavo, Inc. · Sep 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · Sigma Chemical Co. · Mar 1984
PARAMAX SALICYLATE REAGENT
K833003 · American Dade · Oct 1983
TOXI-LAB RAPID SCREEN
K823523 · Marion Laboratories, Inc. · Jan 1983
SALICYLATES
K813431 · Bio-Analytics Laboratories, Inc. · Mar 1982