Cleared Traditional

K922342 - TRI-TECH INC. CUSTOM BLOOD ALCOHOL

K922342 is an FDA 510(k) clearance for TRI-TECH INC. CUSTOM BLOOD ALCOHOL, manufactured by Tri-Tech, Inc.. The device is a Class 2 Toxicology device with product code JKA cleared through the Traditional 510(k) pathway after a 465-day FDA review.

K922342 · Tri-Tech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
465d
Days
Class 2
Risk

K922342 is an FDA 510(k) clearance for the TRI-TECH INC. CUSTOM BLOOD ALCOHOL. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Tri-Tech, Inc. (Durham, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 465 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1675 - 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 Tri-Tech, Inc. devices

FDA 510(k) Submission Details - K922342

510(k) Number K922342 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 19, 1992
Decision Date August 27, 1993
Days to Decision 465 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
378d slower than avg
Panel avg: 87d · This submission: 465d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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.

Regulatory Peers - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 144
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K922342.
DIRECTDRAW SUPERSERUM-G DIRECTDRAW SUPERSERUM-MINI-G
K941159 · International Technidyne Corp. · May 1994
DIRECTDRAW SUPERSERUM-MINI
K935081 · International Technidyne Corp. · Jan 1994
MICROTAINER BRAND TUBE WITH EDTA
K931368 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1993
VACUTAINER BRAND LUER ADAPTER
K931367 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993
VACU-PRO
K922445 · Concord/Portex · Aug 1992
VACUTAINER BRAND LUER ADAPTER
K921520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992