Cleared Traditional

TDX SALICYLATE (K844070) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844070 · Abbott Laboratories · Chemistry device
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Nov 1984
Decision
40d
Days
Class 2
Risk

K844070 is an FDA 510(k) clearance for the TDX SALICYLATE. Classified as Colorimetry, Salicylate (product code DKJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 40 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 Abbott Laboratories devices

Submission Details

510(k) Number K844070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date November 27, 1984
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (DKJ) and FDA review panel - the closest regulatory comparables to K844070.
EASY-TEST SALICYLATE (SAL) #16691
K873425 · Em Diagnostic Systems, Inc. · Oct 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321 · Em Diagnostic Systems, Inc. · Aug 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330 · Em Diagnostic Systems, Inc. · Jul 1987
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243 · Sigma Chemical Co. · Mar 1984
PARAMAX SALICYLATE REAGENT
K833003 · American Dade · Oct 1983