NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

Device Description

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the NoFact IX Deficient Plasma device:

Important Note: The provided document is a 510(k) summary for an in vitro diagnostic device, specifically a deficient plasma product used in laboratory tests. It is not an AI or imaging device, and therefore many sections of your request (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone performance") are not applicable to this type of medical device submission. I will address only the relevant information from the document.

Acceptance Criteria and Device Performance for NoFact IX Deficient Plasma

The device, NoFact IX Deficient Plasma, is an in vitro diagnostic intended for the quantitative determination of Factor IX activity. Its performance is demonstrated through a comparison study with a legally marketed predicate device (STA Deficient IX) and precision testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for an in vitro diagnostic, the "acceptance criteria" are not explicitly stated with numerical thresholds in the provided summary in the same way they might be for an AI model. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device through a strong correlation in quantitative measurements and acceptable precision. The reported performance metrics are derived from this equivalence study and precision assessment.

Performance Metric	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (NoFact IX vs. Predicate)
Comparative Study (Linear Regression)		All Labs (N=233)
- Coefficient of Determination (r²)	Strong correlation with predicate device (typically r² > 0.90 is desired for quantitative comparison)	0.915
- Correlation Coefficient (r)	Strong linear relationship	0.956
- Slope	Close to 1 (indicating proportional agreement)	0.858
- Intercept	Close to 0 (indicating minimal constant bias)	5.729
Precision (CV%) - Normal Control	Acceptable within-run and lot-to-lot variability for an IVD measuring coagulation factors (target typically <10% for CV)	Within-run: 5.1%, Lot-to-Lot: 1.1%, Within-Device: 7.2%
Precision (CV%) - Abnormal Control	Acceptable within-run and lot-to-lot variability	Within-run: 4.6%, Lot-to-Lot: 2.9%, Within-Device: 7.7%
Precision (CV%) - Low FIX Patient	Acceptable within-run and lot-to-lot variability	Within-run: 5.7%, Lot-to-Lot: 2.2%, Within-Device: 7.8%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Comparative Study (Test Set): 233 plasma samples.
Data Provenance: The plasma samples were analyzed across three different laboratories ("sites"). The document does not specify the country of origin, nor whether the samples were collected retrospectively or prospectively. It just indicates they were "plasma samples."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as this is an in vitro diagnostic device where the "ground truth" is established by the highly controlled, quantitative measurement from an established predicate device and internal controls, not expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

This is not applicable for an in vitro diagnostic device that quantifies a substance in plasma. There is no human interpretation or adjudication involved in generating the raw measurement data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. An MRMC study is relevant for imaging or diagnostic tools where human readers interpret results, and the AI is meant to assist that interpretation. This device is a reagent used in an automated laboratory test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of AI algorithms. This device is a reagent; its "standalone" performance is assessed by its ability to accurately measure Factor IX activity in a laboratory setting, which is directly addressed by the comparative study and precision data.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

The Stago PTT-A FIX assay using the predicate STA IX deficient plasma. The comparison seeks to show that the NoFact IX Deficient Plasma yields equivalent quantitative results to this established method.
Known control plasma samples (Normal Control Plasma, Abnormal Control Plasma) and pooled patient plasma with a known Low FIX concentration for precision testing.

8. The Sample Size for the Training Set

This is not applicable. This is not an AI or machine learning device that utilizes a "training set." The device is a manufactured biological reagent.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K102908.

1) Applicant Name and Address

Applicant:	r2 Diagnostics, Inc.
Address:	1801 Commerce DriveSouth Bend, IN 46628
Contact Person:	Marc D. Goldford
Phone #:	574-288-4377
Fax #:	574-288-2272
Email:	marc@r2diagnostics.com
Date of Preparation:	15 November 2010

2) Device Name(s)

Trade Name:	NoFact IX
Classification Name:	Plasma, Factor Deficient (21CFR 864.7290, Product Code GJT)

3) Predicate Device(s)

Stago IX Deficient Plasma (K933432)

4) Device Description(s)

5) Intended Use(s)

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6) Technological Characteristic Summary

Comparison of the submitted kit and the predicate kit is summarized in the table below: a.

Comparison of submitted device NoFact IX to
predicate device STA Deficient IX
Similarities
Item	Submitted Device	Predicate Device
Intended use	NoFact IX Deficient Plasma is ahuman plasma immunodepletedof Factor IX and intended forthe quantitative determinationof Factor IX activity in citratedplasma from patients suspectedof FIX deficiency. FIX activityis based on the activated partialthromboplastin time. For invitro diagnostic use.	STA Deficient IX is animmunodepleted humanplasma intended for use in testsfor the determination of factorIX activity in plasma byanalyzers of the STA linesuitable with this reagent.
Constituent material	Citrated human plasmaimmunodepleted of Factor IX.	Citrated human plasmaimmunodepleted of Factor IX.
Measurement principle	Diluted patient sample is mixedwith factor IX deficient plasmaand then tested with an APTT.In these conditions the clottingtime of the mixture isdependent on theconcentration of FIX in thepatient sample.	Diluted patient sample is mixedwith factor IX deficient plasmaand then tested with an APTT.In these conditions the clottingtime of the mixture isdependent on theconcentration of FIX in thepatient sample.
Format	Lyophilized plasma	Lyophilized plasma
Analyte being tested	Factor IX activity	Factor IX activity

	Differences
Item	Submitted Device	Predicate Device
Reconstituted Stability	2-8C: 8 hrRT: 4 hr	2-8C: not listedRT: not listedOn-board STA Compact: 4 hrs

b. NoFact IX Deficient Plasma was compared to the predicate STA IX Deficient plasma using the Stago PTT-A FIX assay on the STA Compact. Plasma samples were assayed in parallel with the Stago PTT-A assay using the STA IX deficient plasma ("Stago results"), and also with the same assay but where the NoFact IX deficient plasma was substituted for the STA IX deficient plasma ("NoFact results"). A total of two hundred and thirty-three plasma samples in three laboratories

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were analyzed. The linear regression equation of this comparison was: y = 0.858* x + 5.73, with a coefficient of determination of 0.915.

	All Labs	Site 1	Site 2	Site 3
	N=233	N=100	N=80	N=53
Slope	0.858	0.785	0.923	0.817
Intercept	5.729	6.168	5.328	11.206
r2	0.915	0.977	0.907	0.830
r	0.956	0.988	0.988	0.911

The regression statistics by site were:

The Stago PTT-A IX assay was evaluated for precision with three separate lots of NoFact IX ﻥ Deficient Plasma according to the CLSI guideline EP5-A2 "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-20d Edition":

Plasma	Mean FIXactivity, %	% CV, Within-run(S-r)	% CV, Lot-to-Lot(S-lot)	% CV, Within-Device (S-device)
System N(Normal ControlPlasma)N=240	109%	5.1%	1.1%	7.2%
System P(Abnormal ControlPlasma)N=240	43%	4.6%	2.9%	7.7%
Low FIX pooled patientplasmaN=120	14%	5.7%	2.2%	7.8%

NoFact IX Deficient Plasma provides acceptable precision.

NoFact IX Deficient Plasma is substantially equivalent to Stago IX Deficient Plasma.

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

r2 Diagnostics, Inc. c/o Mr. Marc D. Goldford Director, Research and Development 1801 Commerce Dr. South Bend, IN 46628

DEC 1 9 2011

Re: K102908

Trade/Device Name: NoFact IX Deficient Plasma Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GJT Dated: December 7, 2011 Received: December 8, 2011

Dear Mr. Goldford:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Mr. Marc D. Goldford

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Reena Philip

roh

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 102908

Device Name: NoFact IX Deficient Plasma

Indications For Use: NoFact IX Deficient Plasma is a human plasma immunodepleted of Factor IX and intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K102908

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).