Cleared Traditional

K000556 - ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS

K000556 is an FDA 510(k) clearance for ATAC PAK GLUCOSE REAGENT AND ATAC CALIB..., manufactured by Elan Diagnostics. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K000556 · Elan Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
89d
Days
Class 2
Risk

K000556 is an FDA 510(k) clearance for the ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Diagnostics devices

FDA 510(k) Submission Details - K000556

510(k) Number K000556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date May 17, 2000
Days to Decision 89 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
1d slower than avg
Panel avg: 88d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CFR Hexokinase, Glucose

All 135
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K000556.
GLUCOSE (HEXOKINASE)
K011900 · Jas Diagnostics, Inc. · Jul 2001
MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K002199 · Pointe Scientific, Inc., · Nov 2000
SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P
K001403 · Sigma Diagnostics, Inc. · Aug 2000
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics · Feb 2000
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02
K990981 · A.P. Total Care, Inc. · May 1999
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999