Cleared Traditional

K801664 - SERALYZER GLUCOSE TEST MODULE

K801664 is an FDA 510(k) clearance for SERALYZER GLUCOSE TEST MODULE, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801664 · Miles Laboratories, Inc. · Chemistry device
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Aug 1980
Decision
30d
Days
Class 1
Risk

K801664 is an FDA 510(k) clearance for the SERALYZER GLUCOSE TEST MODULE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General 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 862.2100 - 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

FDA 510(k) Submission Details - K801664

510(k) Number K801664 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.

JQP Device Classification - Class 1, General Controls

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQP Calculator/data Processing Module, For Clinical Use

All 55
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K801664.
BCD-HPP41C INTERFACE
K810968 · Dynatech Corp. · Apr 1981
BECKMAN DP-5500 DATA REDUCTION SYSTEM
K802594 · Beckman Instruments, Inc. · Nov 1980
SP 120 SOPHISTICATE
K802251 · Vickers America Medical Corp. · Oct 1980
CENTRIFICHEM SYSTEM MANAGER
K801438 · Union Carbide Corp. · Jul 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · Miles Laboratories, Inc. · Jun 1980
K 750 COMPUTER/DATA PROCESSOR
K801091 · J.T. Baker Chemical Co. · Jun 1980