Cleared Traditional

FACTOR DEFICIENT PLASMAS - FACTOR IX (9) (K972288) - FDA 510(k) Clearance

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

K972288 · Universal Reagents, Inc. · Hematology device
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Jul 1997
Decision
25d
Days
Class 2
Risk

K972288 is an FDA 510(k) clearance for the FACTOR DEFICIENT PLASMAS - FACTOR IX (9). Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Universal Reagents, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology device 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 Universal Reagents, Inc. devices

Submission Details

510(k) Number K972288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1997
Decision Date July 14, 1997
Days to Decision 25 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

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All 189
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