Cleared Traditional

K800677 - REAGENTS FOR DETERM. SERUM IRON IN HUMAN

K800677 is an FDA 510(k) clearance for REAGENTS FOR DETERM. SERUM IRON IN HUMAN, manufactured by Diagnostic Solutions, Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K800677 · Diagnostic Solutions, Inc. · Chemistry device
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May 1980
Decision
63d
Days
Class 1
Risk

K800677 is an FDA 510(k) clearance for the REAGENTS FOR DETERM. SERUM IRON IN HUMAN. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Diagnostic Solutions, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 63 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 Solutions, Inc. devices

FDA 510(k) Submission Details - K800677

510(k) Number K800677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1980
Decision Date May 28, 1980
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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)

All 61
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K800677.
SPIN CHEM REAGENTS & STANDARDS
K821184 · Smithkline Diagnostics, Inc. · May 1982
SERUM IRON REAGENT SET
K812840 · Anco Medical Reagents & Assoc. · Dec 1981
DIRECT IRON REAGENT SET
K812777 · The Dow Chemical Co. · Oct 1981
TOTAL IRON IN SERUM
K782160 · Fisher Scientific Co., LLC · Jan 1979
IRON BINDING CAPICITY MODEL 0370
K781865 · Stanbio Laboratory · Dec 1978
SERUM IRON
K771838 · Gamma Enterprises, Inc. · Nov 1977