Cleared Traditional

K990280 - BIONIKE AQ BARBITURATE TEST

K990280 is an FDA 510(k) clearance for BIONIKE AQ BARBITURATE TEST, manufactured by Bionike, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K990280 · Bionike, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
151d
Days
Class 2
Risk

K990280 is an FDA 510(k) clearance for the BIONIKE AQ BARBITURATE TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Bionike, Inc. (Simi Valley, US). The FDA issued a Cleared decision on June 28, 1999 after a review of 151 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 Bionike, Inc. devices

FDA 510(k) Submission Details - K990280

510(k) Number K990280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1999
Decision Date June 28, 1999
Days to Decision 151 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
64d slower than avg
Panel avg: 87d · This submission: 151d
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 K990280.
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · OraSure Technologies, Inc. · Dec 2000
URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
K000459 · Dade Behring, Inc. · Apr 2000
RAPIDONE- BARBITURATE TEST
K992451 · American Bio Medica Corp. · Apr 2000
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · Roche Diagnostics Corp. · Jun 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
K983698 · Roche Diagnostic Systems, Inc. · May 1999
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
K991018 · Princeton BioMeditech Corp. · Apr 1999