Cleared Traditional

K801665 - SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH)

K801665 is the FDA 510(k) clearance for SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801665 · Miles Laboratories, Inc. · Chemistry device
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Aug 1980
Decision
30d
Days
Class 2
Risk

K801665 is an FDA 510(k) clearance for the SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH). Classified as Calibrator, Primary (product code JIS), 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 862.1150 - 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 K801665 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 JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 93
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K801665.
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · Boehringer Mannheim Corp. · Apr 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · Syva Co. · Mar 1981
CREATININE STANDARDS
K802631 · Gilford Diagnostics · Dec 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · Syva Co. · Jun 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1980
PIPET CALIBRATION KIT
K800062 · Streck Laboratories, Inc. · Feb 1980