Cleared Traditional

K000958 - ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

K000958 is an FDA 510(k) clearance for ATAC PAK BUN REAGENT AND ATAC CALIBRATO..., manufactured by Elan Holdings, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K000958 · Elan Holdings, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
61d
Days
Class 2
Risk

K000958 is an FDA 510(k) clearance for the ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on May 24, 2000 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Elan Holdings, Inc. devices

FDA 510(k) Submission Details - K000958

510(k) Number K000958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2000
Decision Date May 24, 2000
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 107
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K000958.
RAICHEM BUN RATE REAGENT
K012649 · Hemagen Diagnostics, Inc. · Oct 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · Wiener Laboratories Saic · Sep 2001
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · Diagnostic Chemicals , Ltd. · Sep 2000
WAKO L-TYPE UN TEST
K993925 · Wako Chemicals USA, Inc. · Apr 2000
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178 · Diagnostic Chemicals , Ltd. · Oct 1999
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
K992800 · Sigma Diagnostics, Inc. · Sep 1999