Cleared Traditional

K020816 - IRON-PC-SL ASSAY MODEL # 151-10, 151-26

K020816 is an FDA 510(k) clearance for IRON-PC-SL ASSAY MODEL # 151-10, manufactured by Diagnostic Chemicals , Ltd.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K020816 · Diagnostic Chemicals , Ltd. · Chemistry device
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May 2002
Decision
62d
Days
Class 1
Risk

K020816 is an FDA 510(k) clearance for the IRON-PC-SL ASSAY MODEL # 151-10, 151-26. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on May 14, 2002 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 Diagnostic Chemicals , Ltd. devices

FDA 510(k) Submission Details - K020816

510(k) Number K020816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2002
Decision Date May 14, 2002
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

JIY Device Classification - Class 1, General Controls

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - JIY Photometric Method, Iron (non-heme)

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