Cleared Traditional

K935568 - PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS

K935568 is an FDA 510(k) clearance for PARAMAX PHENOBARBITAL REAGENT AND CALIB..., manufactured by Baxter Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DLZ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K935568 · Baxter Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
113d
Days
Class 2
Risk

K935568 is an FDA 510(k) clearance for the PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS. Classified as Enzyme Immunoassay, Phenobarbital (product code DLZ), Class II - Special Controls.

Submitted by Baxter Diagnostics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3660 - 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 Baxter Diagnostics, Inc. devices

FDA 510(k) Submission Details - K935568

510(k) Number K935568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1993
Decision Date March 11, 1994
Days to Decision 113 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
26d slower than avg
Panel avg: 87d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLZ Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - DLZ Enzyme Immunoassay, Phenobarbital

All 33
Devices cleared under the same product code (DLZ) and FDA review panel - the closest regulatory comparables to K935568.
IL TEST PHENOBARBITAL CALIBRATORS
K943981 · Instrumentation Laboratory CO · Jan 1995
PHENOBARBITAL FLEX REAGENT CARTRIDGE
K944932 · Dupont Medical Products · Dec 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501 · Schiapparelli Biosystems, Inc. · Oct 1994
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · Syva Co. · Aug 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355 · Instrumentation Laboratory CO · Apr 1991
OPUS PHENOBARBITAL TEST SYSTEM
K896861 · Pb Diagnostic Systems, Inc. · Jan 1990