UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA

• K Number: K964270
• Device Name: UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
• Manufacturer: UNIVERSAL REAGENTS, INC.
• Date Cleared: 1996-12-18 ( 54 days)
• Product Code: GGP
• Regulation Number: 864.7290
• Type: Traditional
• Panel: Hematology
• Reference & Predicate Devices: K792507
• Predicate For: N/A

Intended Use

Indicated use - Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

Environment of use: Clinical laboratories

Device Description

Factor deficient plasma to be free of antigen of Factor V utilized in in vitro diagnostic use

AI/ML Overview

The provided text describes a medical device, "Factor deficient coagulation plasma - V," and compares it to a predicate device, Helena - K792507 - Factor V. The document does not describe a study involving machine learning or AI. Therefore, I cannot extract information related to AI/ML acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), or training set details.

The document focuses on the intended use, design, materials, and performance testing for a diagnostic reagent. The performance testing section mentions:

Acceptance Criteria and Reported Device Performance (as described for this diagnostic reagent)

Acceptance Criteria (Performance Testing)	Reported Device Performance (Intended Product)
Compare assay to known sample	Yes
Negative by FDA approved test for HIV 1/2 and HBsAG	Yes
Negative by FDA approved test for HCV and HIV-1ag	Yes
Deficiency of relevant factor less than 1%	Yes
Negative for HIV and HBsAG	Yes
Negative for HCV, HIV-1ag	Yes
No inhibitor present	Yes

Study Details Related to AI/ML: Not applicable. The document describes a traditional in-vitro diagnostic device, not an AI/ML system. There is no information regarding:

1. Sample size for test set or data provenance.
2. Number or qualifications of experts.
3. Adjudication method.
4. MRMC comparative effectiveness study or effect size.
5. Standalone performance.
6. Type of ground truth (beyond "known sample" for assay comparison).
7. Sample size for training set.
8. How ground truth for training set was established.

Summary

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UNIVERSAL REAGENTS, INC.

2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: [phone] FAX: [phone]

DEC 1 8 1996

K964370

Non-Confidential Summary of Safety and Effectiveness

October 17, 1996

page 1 of 2

Universal Reagents, Inc.2858 N. Pennsylvania St.Indianapolis, IN 46205	Tel - [phone]Fax - [phone]
Official contact:	Jorge Miller, Director, Coagulation Products
Proprietary or Trade Name:	Factor deficient coagulation plasma - V
Common/Usual Name:	Qualitative and Quantitative Factor Deficiency Test - V
Classification Name:	Qualitative and Quantitative Factor Deficiency Test
Intended device:	Factor deficient coagulation plasma - V
Predicate devices:	Helena - K792507 - Factor V
Device description:	Factor deficient plasma to be free of antigen of Factor V utilizedin in vitro diagnostic use

Intended use:

Indicated use - Factor deficient plasma, Factor - V is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

Environment of use: Clinical laboratories

Comparison to predicate devices:

Attribute	Intended product	Helena
Use
Indicated for use in determinationof coagulation of plasma	Yes	Yes
In vitro diagnostic use	Yes	Yes
Used as a quantitative assay	Yes	Yes
Design
Factor V deficient plasmas offered	Yes	Yes

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Non-Confidential Summary of Safety and Effectiveness (continued)

October 17, 1996

page 2 of 2

Comparison to predicate devices: (continued)

Attribute	Intendedproducts	Helena
Packaging either -Frozen or Dry / Iyophilized	Yes	Yes
Can be used with differentinstruments and reagents permanufacturer instructions	Yes	Yes
Materials
Donor human plasma	Yes	Yes
Various buffers	Yes	Yes
Performance Testing
Compare assay to known sample	Yes	Yes
Negative by FDA approved test forHIV 1/2 and HBsAG	Yes	Yes
Negative by FDA approved test forHCV and HIV-1ag	Yes	not known
Donor criteria
Deficiency of relevant factorless than 1%	Yes	not known
Negative for HIV and HBsAG	Yes	Yes
Negative for HCV, HIV-1ag	Yes	not known
No inhibitor present	Yes	not known

Differences

The only difference is that the intended product is claimed to be negative for HCV and HIV-1ag by an FDA approved test.

Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device.

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).