Cleared Traditional

K860501 - FLAME PHOTOMETER STANDARD (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K860501 · Medical Specialties, Inc. · Chemistry device
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Apr 1986
Decision
55d
Days
Class 2
Risk

K860501 is an FDA 510(k) clearance for the FLAME PHOTOMETER STANDARD. Classified as Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate (product code JLJ), Class II - Special Controls.

Submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1315 - 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 Medical Specialties, Inc. devices

Submission Details

510(k) Number K860501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date April 07, 1986
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JLJ Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1315
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.