Cleared Traditional

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

K945908 is an FDA 510(k) clearance for GLUCOSE (HK) REAGENT (PROCEDURE NO.16), manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K945908

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.

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 136
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
GLUCOSE QVET
K942963 · Prisma Systems · Dec 1994
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · Heraeus Kulzer, Inc. · Dec 1993