Cleared Traditional

K032764 - BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)

Also marketed or referenced as:
CAT# 0141 (5000 TESTS KIT)

K032764 is an FDA 510(k) clearance for BARBITURATE ENZYME IMMUNOASSAY, manufactured by Lin-Zhi International, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K032764 · Lin-Zhi International, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
59d
Days
Class 2
Risk

K032764 is an FDA 510(k) clearance for the BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT). Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on November 3, 2003 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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: 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 Lin-Zhi International, Inc. devices

FDA 510(k) Submission Details - K032764

510(k) Number K032764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date November 03, 2003
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 87d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 89
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K032764.
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BARBITURATES
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