Cleared Traditional

K870631 - FAST GLUCOSE

K870631 is the FDA 510(k) clearance for FAST GLUCOSE by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K870631 · Sclavo, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1987
Decision
28d
Days
Class 2
Risk

K870631 is an FDA 510(k) clearance for the FAST GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on March 13, 1987 after a review of 28 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 Sclavo, Inc. devices

Submission Details

510(k) Number K870631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1987
Decision Date March 13, 1987
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 194
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K870631.
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · Miles Laboratories, Inc. · Dec 1987
BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENT
K873117 · Biotrol, USA, Inc. · Aug 1987
MODIFICATION OF ACCU-CHEK II
K863481 · Boehringer Mannheim Corp. · Apr 1987
MPX SYSTEM, GLUCOSE TEST SYSTEM
K864322 · Lifescan, Inc. · Feb 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · Miles Laboratories, Inc. · Feb 1987
ABBOTT SPECTRUM GLUCOSE REAGENT
K864224 · Abbott Laboratories · Jan 1987