Cleared Traditional

K873835 - GLUCOSE-HK REAGENT

K873835 is the FDA 510(k) clearance for GLUCOSE-HK REAGENT by Intersect Systems, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K873835 · Intersect Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
64d
Days
Class 2
Risk

K873835 is an FDA 510(k) clearance for the GLUCOSE-HK REAGENT. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on November 24, 1987 after a review of 64 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K873835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1987
Decision Date November 24, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 108
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K873835.
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · Em Diagnostic Systems, Inc. · Nov 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · Abbott Laboratories · Aug 1988
GLUCOSE (HEXOKINASE)
K874846 · Tech-Co, Inc. · Mar 1988
MODIFIED PARAMAX GLUCOSE REAGENT
K873936 · Baxter Healthcare Corp · Nov 1987
GLUCOSE HK PROCEDURE
K863259 · Data Medical Associates, Inc. · Sep 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · Sterling Diagnostics, Inc. · Apr 1986