Cleared Traditional

K961588 - TOTAL IRON (NITRO-PAPS) REAGENT SET

K961588 is an FDA 510(k) clearance for TOTAL IRON (NITRO-PAPS) REAGENT SET, manufactured by Pointe Scientific, Inc.,. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K961588 · Pointe Scientific, Inc., · Chemistry device
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Nov 1996
Decision
208d
Days
Class 1
Risk

K961588 is an FDA 510(k) clearance for the TOTAL IRON (NITRO-PAPS) REAGENT SET. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on November 18, 1996 after a review of 208 days - an extended review 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: 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 Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K961588

510(k) Number K961588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1996
Decision Date November 18, 1996
Days to Decision 208 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
120d slower than avg
Panel avg: 88d · This submission: 208d
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 K961588.
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