Cleared Traditional

K771713 - TEK-CHEK-2

K771713 is the FDA 510(k) clearance for TEK-CHEK-2 by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K771713 · Miles Laboratories, Inc. · Chemistry device
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Oct 1977
Decision
36d
Days
Class 1
Risk

K771713 is an FDA 510(k) clearance for the TEK-CHEK-2. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K771713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1977
Decision Date October 18, 1977
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJW Urinalysis Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJW Urinalysis Controls (assayed And Unassayed)

All 35
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K771713.
CONTROL STRIP FOR VISUAL URINALYSIS
K781961 · Miles Laboratories, Inc. · Feb 1979
CHEMSTRIP CONTROL
K781691 · Boehringer Mannheim Corp. · Dec 1978
KOVA TROL III
K780482 · Icl Scientific · May 1978
URINALYSIS PROFICIENCY
K770390 · Miles Laboratories, Inc. · May 1977
PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
K760863 · Sigma Chemical Co. · Nov 1976