Cleared Traditional

BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) (K033885) - FDA 510(k) Clearance

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

K033885 · Lin-Zhi International, Inc. · Toxicology device
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May 2004
Decision
156d
Days
Class 2
Risk

K033885 is an FDA 510(k) clearance for the BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST 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 May 19, 2004 after a review of 156 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K033885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2003
Decision Date May 19, 2004
Days to Decision 156 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 87d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 99
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