Cleared Traditional

CRACK-IT CHAP SCREEN (K874389) - FDA 510(k) Clearance

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

K874389 · Sakers, Inc. · Toxicology device
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Feb 1989
Decision
469d
Days
Class 2
Risk

K874389 is an FDA 510(k) clearance for the CRACK-IT CHAP SCREEN. Classified as Thin Layer Chromatography, Cocaine (product code DMN), Class II - Special Controls.

Submitted by Sakers, Inc. (Westville, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Sakers, Inc. devices

Submission Details

510(k) Number K874389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1987
Decision Date February 07, 1989
Days to Decision 469 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
382d slower than avg
Panel avg: 87d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DMN Thin Layer Chromatography, Cocaine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 Toxicology devices follow this clearance model.