Cleared Traditional

K871976 - MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919

K871976 is an FDA 510(k) clearance for MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919, manufactured by Simmler, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K871976 · Simmler, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1987
Decision
14d
Days
Class 2
Risk

K871976 is an FDA 510(k) clearance for the MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Simmler, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 14 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 Simmler, Inc. devices

FDA 510(k) Submission Details - K871976

510(k) Number K871976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1987
Decision Date June 05, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 137
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K871976.
GLUCOSE (HEXOKINASE)
K874846 · Tech-Co, Inc. · Mar 1988
GLUCOSE-HK REAGENT
K873835 · Intersect Systems, Inc. · Nov 1987
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · Baxter Healthcare Corp · Nov 1987
ULTRA-VIOLET GLUCOSE REAGENT KIT
K871456 · Biochemical Trade, Inc. · Apr 1987
GLUCOSE HK PROCEDURE
K863259 · Data Medical Associates, Inc. · Sep 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · Sterling Diagnostics, Inc. · Apr 1986