This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XII. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

Device Description

Factor deficient plasma to be free of antigen of Factor XII utilized in in vitro diagnostic use. Factor immunodeficient plasma XII is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Factor deficient coagulation plasma - XII" device.

Unfortunately, the provided document is a 510(k) summary for a medical device (Factor deficient coagulation plasma - XII) and does not contain information about acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (Pacific Hemostasis Factor XII). Substantial equivalence means the new device is as safe and effective as a legally marketed device that does not require premarket approval. It's a regulatory pathway, not a detailed performance study with explicit acceptance criteria and statistical analysis as one might find for a novel device or a clinical trial.

However, I can extract what is implied to be performance aspects they are comparing and some "claims" that function like implicit criteria.

Therefore, for your request, I will explain why much of the requested information is not available and then approximate answers based on the provided text's context of substantial equivalence.

Explanation of Missing Information

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) submission. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. It does not typically include:

Explicit Acceptance Criteria: While performance characteristics are compared, specific numerical thresholds for acceptance (e.g., "sensitivity must be >90%") are usually not stated for substantial equivalence. The goal is to show the device performs similarly to the predicate.
Detailed Study Design/Results: It summarizes comparison points rather than presenting a full study protocol, data analysis, or statistical results.
Sample Sizes, Data Provenance, Ground Truth Establishment: These are details of a formal study that are generally not part of a 510(k) summary, unless it's a novel device or there's a specific performance experiment conducted to bridge a difference.
Expert Consensus/Adjudication, MRMC studies, Standalone Performance: These are methodologies typically associated with clinical performance evaluations for diagnostic accuracy, especially for image-based or more complex diagnostic devices. This device is a reagent for a laboratory clotting assay.

Attempted Answers Based on Available Information

Since the document focuses on substantial equivalence, the "acceptance criteria" are implicitly met if the device is comparable to the predicate device in the listed attributes.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Comparison & Claims)	Reported Device Performance (Intended Product)
Functional Equivalence
Use: Indicated for use in determination of coagulation of plasma	Yes (Matches Predicate)
Use: In vitro diagnostic use	Yes (Matches Predicate)
Use: Used as a quantitative assay	Yes (Matches Predicate)
Design: Factor XII deficient plasma offered	Yes (Matches Predicate)
Packaging: Frozen or Dry / lyophilized	Yes (Matches Predicate)
Compatibility: Can be used with different instruments and reagents per manufacturer instructions	Yes (Matches Predicate)
Materials: Donor human plasma	Yes (Matches Predicate)
Materials: Various buffers	Yes (Matches Predicate)
Safety & Quality Testing
Performance Testing: Compare assay to known sample	Yes (Matches Predicate)
Negative by FDA approved test for HIV 1/2 and HBsAG	Yes (Matches Predicate)
Deficiency of relevant factor less than 1%	Yes (Matches Predicate claim, not explicitly in predicate comparison)
No inhibitor present	Yes (Claim, not explicitly in predicate comparison)
Additional Claims (New compared to predicate where "not known")
Negative by FDA approved test for HCV and HIV-1ag	Yes (Claim)

2. Sample size used for the test set and the data provenance

Not explicitly stated. The document refers to "Performance Testing: Compare assay to known sample" which implies some form of testing, but the sample size (number of "known samples," or patient samples if used) is not provided.
Data Provenance: Not stated. It would likely be internal testing data from Universal Reagents, Inc., potentially using commercially available materials or characterized in-house samples. Retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not stated. For a coagulation reagent, the "ground truth" would typically come from reference methods, certified reference materials, or well-characterized patient samples with established diagnoses, not expert consensus in the same way an imaging study would use radiologists. The document uses phrases like "known sample" and "Deficiency of relevant factor less than 1%," implying laboratory characterization.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not stated. This refers to methods for resolving discrepancies among expert readers, which isn't relevant for a reagent's performance testing where objective measurements against standards are expected.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This type of study is for diagnostic devices that assist human interpretation, often in imaging or pathology. This device is a laboratory reagent; there are no "human readers" in this context that would be "assisted by AI."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a reagent for an in vitro diagnostic test. It's not an AI algorithm. Its "standalone performance" is its ability to correctly aid in the quantitative determination of Factor XII deficiency when used in a lab assay. The document implies this is assessed by comparing its assay results to "known samples."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Based on "Compare assay to known sample" and "Deficiency of relevant factor less than 1%", the ground truth would be laboratory characterization against established reference standards (e.g., certified Factor XII deficient plasma, or well-characterized patient samples), and likely comparison to the predicate device's performance using these same known samples.

8. The sample size for the training set

Not applicable/Not stated. This device is a reagent, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014

K973143

SEP 2 5 1997

Non-Confidential Summary of Safety and Effectiveness August 21, 1997 page 1 of 2

Universal Reagents, Inc. 2858 N. Pennsylvania St. Indianapolis, IN 46205

Tel - (317) 926-0006

Fax - (317) 926-0014

Official contact:	Jorge Miller, Director, Coagulation Products
Proprietary or Trade Name:	Factor deficient coagulation plasma - XII
Common/Usual Name:	Qualitative and Quantitative Factor Deficiency Test - XII
Classification Name:	Qualitative and Quantitative Factor Deficiency Test
Intended device:	Factor deficient coagulation plasma - XII
Predicate devices:	Pacific Hemostasis Factor XII - K# unknown
Device description:	Factor deficient plasma to be free of antigen of Factor XIIutilized in in vitro diagnostic use.

Intended use:

Indicated use - Factor deficient plasma, Factor - XII is a human plasma immunodepleted of the
specific factor and intended for use in the quantitative determination of the 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	Pacific Hemostasis
Use
Indicated for use in determination of coagulation of plasma	Yes	Yes
In vitro diagnostic use	Yes	Yes
Used as a quantitative assay	Yes	Yes
Design
Factor XII deficient plasma offered	Yes	Yes
page 3 of 36

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Non-Confidential Summary of Safety and Effectiveness

August 21, 1997

page 2 of 2

Comparison to predicate devices: (continued)

Attribute	Intendedproduct	Pacific Hemostasis
Packaging either -Frozen or Dry / lyophilized	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
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.

page 4 of 36

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 5 1997

Jorge Miller Director, Coaqulation Products Universal Reagents, Inc. 2858 North Pennsylvania Street Indianapolis, Indiana 46205

Re : K973143 URI Factor XII Requlatory Class: II GJT, GGP Product Code: September 8, 1997 Dated: Received: September 15, 1997

Dear Mr. Miller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section # 3

Labeling (continued)

C. Indications for Use Statement

Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number:	(to be assigned)
Device Name:	Factor Deficient Coagulation PlasmaFactor - XII (12)
Indications for Use:
Indicated use -	This product is intended for use in the quantitative determination offactor levels in patients suspected of congenital or acquired deficiencyof this coagulation protein or factor, XII.
	Factor immunodeficient plasma XII is made from human plasma thathas been artificially depleted. This plasma has normal levels of all otherfactors.
Claims -	Negative per FDA approved test for HIV 1/2, HBsAG, HCV, HIV-1ag
Packaging -	FrozenFreeze dried - Lyophilized

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number. 197343

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

page 7 of 36

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).