Cleared Special

K010934 - EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229

K010934 is an FDA 510(k) clearance for EMIT II PLUS BARBITUATE ASSAY, manufactured by Syva Co., Dade Behring, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Special 510(k) pathway after a 23-day FDA review.

K010934 · Syva Co., Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
23d
Days
Class 2
Risk

K010934 is an FDA 510(k) clearance for the EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Syva Co., Dade Behring, Inc. devices

FDA 510(k) Submission Details - K010934

510(k) Number K010934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date April 20, 2001
Days to Decision 23 days
Submission Type Special
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 faster than avg
Panel avg: 87d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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
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PROFILE-ER
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