Cleared Traditional

K832097 - PHENOBARTIAL ASSAY USE ON COBAS-BIO

K832097 is the FDA 510(k) clearance for PHENOBARTIAL ASSAY USE ON COBAS-BIO by Syva Co.. It is a Class 2 Chemistry device (product code DLZ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K832097 · Syva Co. · Chemistry device
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Aug 1983
Decision
43d
Days
Class 2
Risk

K832097 is an FDA 510(k) clearance for the PHENOBARTIAL ASSAY USE ON COBAS-BIO. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3660 - the FDA in vitro diagnostics and chemistry 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 Syva Co. devices

Submission Details

510(k) Number K832097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1983
Decision Date August 11, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLZ Enzyme Immunoassay, Phenobarbital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3660
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 Chemistry devices follow this clearance model.

Regulatory Peers - DLZ Enzyme Immunoassay, Phenobarbital

All 31
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K832097.
CHEM KIT PHENOBARBITAL
K833796 · Abbott Laboratories · Jan 1984
EMIT QST PHENOBARBITAL ASSAY
K834216 · Syva Co. · Jan 1984
A-GENT PHENOBARBITAL
K832457 · Abbott Laboratories · Sep 1983
EMIT-ST SERUM PHENOBARBITAL ASSAY
K811621 · Syva Co. · Jun 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · Kallestad Laboratories, Inc. · May 1981
PHENOBARBITAL REAGENT TEST KIT
K802039 · Beckman Instruments, Inc. · Oct 1980