Cleared Traditional

K870214 - MODIFIED SALTEX REAGENT STRIPS

K870214 is an FDA 510(k) clearance for MODIFIED SALTEX REAGENT STRIPS, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CHK cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K870214 · Miles Laboratories, Inc. · Chemistry device
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Jun 1987
Decision
160d
Days
Class 2
Risk

K870214 is an FDA 510(k) clearance for the MODIFIED SALTEX REAGENT STRIPS. Classified as Mercuric Nitrate And Diphenyl Carbazone (titrimetric), Chloride (product code CHK), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on June 29, 1987 after a review of 160 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K870214

510(k) Number K870214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date June 29, 1987
Days to Decision 160 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
72d slower than avg
Panel avg: 88d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHK Device Classification - Class 2, Special Controls

Product Code CHK Mercuric Nitrate And Diphenyl Carbazone (titrimetric), Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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.