Cleared Traditional

K984574 - INFINITY GLUCOSE REAGENT

K984574 is an FDA 510(k) clearance for INFINITY GLUCOSE REAGENT, 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 50-day FDA review.

K984574 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
50d
Days
Class 2
Risk

K984574 is an FDA 510(k) clearance for the INFINITY GLUCOSE REAGENT. 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 February 11, 1999 after a review of 50 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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K984574

510(k) Number K984574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date February 11, 1999
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K984574.
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
N-ASSAY GLU-UL
K980883 · Crestat Diagnostics, Inc. · Sep 1998
GLU
K981185 · Abbott Laboratories · May 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026 · Trace America, Inc. · Mar 1998