Cleared Traditional

K801663 - SERALYZER GLUCOSE REAGENT STRIPS

K801663 is the FDA 510(k) clearance for SERALYZER GLUCOSE REAGENT STRIPS by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801663 · Miles Laboratories, Inc. · Chemistry device
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Aug 1980
Decision
30d
Days
Class 2
Risk

K801663 is an FDA 510(k) clearance for the SERALYZER GLUCOSE REAGENT STRIPS. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 30 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K801663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1980
Decision Date August 20, 1980
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K801663.
SERALYZER SYSTEM
K810639 · Miles Laboratories, Inc. · Mar 1981
GLUCOSE OXIDASE
K810674 · Pointe Scientific, Inc., · Mar 1981
GLUCOSE (TRINDER) REAGENT
K801600 · Gilford Diagnostics · Aug 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071 · Sherwood Medical Industries · May 1980
GLUCOSE OXIDASE REAGENT KIT
K800070 · Fisher Scientific Co., LLC · Feb 1980
NEOCHROME II GLUCOSE, #4044
K792534 · American Monitor Corp. · Jan 1980