Cleared Traditional

K000006 - IMMULITE PHENYTOIN

K000006 is the FDA 510(k) clearance for IMMULITE PHENYTOIN by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code DIP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K000006 · Diagnostic Products Corp. · Toxicology device
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Feb 2000
Decision
56d
Days
Class 2
Risk

K000006 is an FDA 510(k) clearance for the IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2,.... Classified as Enzyme Immunoassay, Diphenylhydantoin (product code DIP), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 28, 2000 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3350 - 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: 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K000006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2000
Decision Date February 28, 2000
Days to Decision 56 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
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIP Enzyme Immunoassay, Diphenylhydantoin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3350
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 - DIP Enzyme Immunoassay, Diphenylhydantoin

All 33
Devices cleared under the same product code (DIP) and FDA review panel - the closest regulatory comparables to K000006.
ROCHE ONLINE TDM PHENYTOIN
K030428 · Roche Diagnostics Corp. · Apr 2003
RANDOX PHENYTOIN
K011393 · Randox Laboratories, Ltd. · Dec 2001
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
K011347 · Syva Co. · May 2001
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
K993026 · Syva Co. · Jan 2000
CEDIA PHENYTOIN II ASSAY
K963840 · Boehringer Mannheim Corp. · Nov 1996
IL TEST PHENYTION CALIBRATORS
K943980 · Instrumentation Laboratory CO · May 1995