Cleared Traditional

K945908 - GLUCOSE (HK) REAGENT (PROCEDURE NO.16)

K945908 is the FDA 510(k) clearance for GLUCOSE (HK) REAGENT (PROCEDURE NO.16) by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K945908 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
157d
Days
Class 2
Risk

K945908 is an FDA 510(k) clearance for the GLUCOSE (HK) REAGENT (PROCEDURE NO.16). Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on May 8, 1995 after a review of 157 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K945908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1994
Decision Date May 08, 1995
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 88d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K945908.
ROCHE REAGENT FOR GLUCOSE
K953847 · Roche Diagnostic Systems, Inc. · Feb 1996
DMA GLUCOSE HEXOKINASE U.V. PROCEDURE
K952437 · Data Medical Associates, Inc. · Oct 1995
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
K951058 · Heraeus Kulzer, Inc. · Jun 1995
OLYMPUS GLUCOSE REAGENT
K944406 · Olympus America, Inc. · Mar 1995
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · Heraeus Kulzer, Inc. · Dec 1993
IL TEST GLUCOSE
K931402 · Instrumentation Laboratory CO · Oct 1993