(446 days)
Not Found
No
The summary describes a biological reagent (deficient plasma) used in a standard laboratory assay (activated partial thromboplastin time) for measuring Factor VIII activity. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML. The performance studies focus on standard analytical metrics like linear regression and precision.
No.
The device is described as being for "in vitro diagnostic use" and is intended for the "quantitative determination of Factor VIII activity," not for treating or preventing disease.
Yes
The device is described as "intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency," and specifically states "For in vitro diagnostic use." These phrases indicate its function is to provide information for diagnosis.
No
The device description clearly states it is a "human plasma immunodepleted of Factor VIII," indicating it is a biological reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
The "Device Description" section also states: "For in vitro diagnostic use."
N/A
Intended Use / Indications for Use
NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
Product codes
GJT
Device Description
NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
NoFact VIII Deficient Plasma was compared to the predicate STA FVIII Deficient plasma using the Stago PTT-A FVIII assay on the STA Compact. Plasma samples were assayed in parallel with the Stago PTT-A assay using the STA FVIII deficient plasma ("Stago results"), and also with the same assay but where the NoFact VIII deficient plasma was substituted for the STA FVIII deficient plasma ("NoFact results"). A total of two hundred thirty three frozen plasma samples in three laboratories were analyzed. The linear regression equation of this comparison was: y = 0.8453x + 4.2111, with a coefficient of determination of 0.9683. The Stago PTT-A FVIII assay was evaluated for precision with three lots of NoFact VIII Deficient Plasma according to the CLSI guideline EP5-A2 "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-200 Edition".
Key Metrics
Comparison with predicate:
Slope (All Labs): 0.845 (0.825-0.865)
Intercept (All Labs): 4.2 (1.9-6.5)
R2 (All Labs): 0.968
Precision:
System N (Normal Control Plasma) n=240: Mean FVIII activity 91.6%, % CV, Within-run (S-r) 4.2%, % CV, Lot-to-Lot (S-lot) 0.63%, % CV, Within-Device (S-device) 6.8%
System P (Abnormal Control Plasma) n=240: Mean FVIII activity 33.3%, % CV, Within-run (S-r) 4.9%, % CV, Lot-to-Lot (S-lot) 3.8%, % CV, Within-Device (S-device) 8.0%
Low FVIII pooled patient plasma n=120: Mean FVIII activity 11.8%, % CV, Within-run (S-r) 5.7%, % CV, Lot-to-Lot (S-lot) 0.0%, % CV, Within-Device (S-device) 8.5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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: K102851.
Applicant Name and Address 1)
| Applicant: | r2 Diagnostics, Inc. |
|---|---|
| Address: | 1801 Commerce Drive |
| South 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 VIII Deficient Plasma |
|---|---|
| Classification Name: | Plasma, Factor Deficient (21CFR 864.7290, Product Code GJT |
3) Predicate Device(s)
Stago VIII Deficient Plasma (K892859)
4) Device Description(s)
NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
5) Intended Use(s)
NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.
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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 VIII Deficient Plasma to | ||
|---|---|---|
| predicate device STA Deficient VIII | ||
| Similarities | ||
| Item | Submitted Device | Predicate Device |
| Intended use | NoFact VIII Deficient Plasma | |
| is a human plasma | ||
| immunodepleted of Factor VIII | ||
| and intended for the quantitative | ||
| determination of Factor VIII | ||
| activity in citrated plasma from | ||
| patients suspected of FVIII | ||
| deficiency. FVIII activity is | ||
| based on the activated partial | ||
| thromboplastin time. For in | ||
| vitro diagnostic use. | STA Deficient VIII is an | |
| immunodepleted human | ||
| plasma intended for use in tests | ||
| for the determination of factor | ||
| VIII activity in plasma by | ||
| analyzers of the STA line | ||
| suitable with this reagent. | ||
| Constituent material | Citrated human plasma | |
| immunodepleted of Factor VIII. | Citrated human plasma | |
| immunodepleted of Factor VIII. | ||
| Measurement principle | Diluted patient sample is mixed | |
| with factor VIII deficient plasma | ||
| and then tested with an APTT. | ||
| In these conditions the clotting | ||
| time of the mixture is | ||
| dependent on the | ||
| concentration of FVIII in the | ||
| patient sample. | Diluted patient sample is mixed | |
| with factor VIII deficient plasma | ||
| and then tested with an APTT. | ||
| In these conditions the clotting | ||
| time of the mixture is | ||
| dependent on the | ||
| concentration of FVIII in the | ||
| patient sample. | ||
| Format | Lyophilized plasma | Lyophilized plasma |
| Analyte being tested | Factor VIII activity | Factor VIII activity |
| Differences | ||
| Item | Submitted Device | Predicate Device |
| Reconstituted Stability | 2-8C: 8 hr | |
| RT: 4 hr | 2-8C: not listed | |
| RT: not listed | ||
| On-board STA Compact: 4 hrs |
- NoFact VIII Deficient Plasma was compared to the predicate STA FVIII Deficient plasma using the ﻘ Stago PTT-A FVIII assay on the STA Compact. Plasma samples were assayed in parallel with the Stago PTT-A assay using the STA FVIII deficient plasma ("Stago results"), and also with the same assay but where the NoFact VIII deficient plasma was substituted for the STA FVIII deficient plasma ("NoFact results"). A total of two hundred thirty three frozen plasma samples in three
2
laboratories were analyzed. The linear regression equation of this comparison was: y = 0.8453x + 4.2111, with a coefficient of determination of 0.9683.
| All Labs | Site 1 | Site 2 | Site 3 | |
|---|---|---|---|---|
| n=233 | n=90 | n=90 | n=53 | |
| Slope | 0.845 (0.825-0.865) | 0.861 (0.844-0.878) | 0.914 (0.891-0.936) | 0.831 (0.777-0.884) |
| Intercept | 4.2 (1.9-6.5) | 2.8 (1.1-4.5) | 2.5 (-0.1-5.1) | 5.9 (-0.606-12.422) |
| R2 | 0.968 | 0.991 | 0.986 | 0.953 |
The regression statistics (with 95% confidence intervals for slope and intercept) by site were:
- The Stago PTT-A FVIII assay was evaluated for precision with three lots of NoFact VIII Deficient ﻦ Plasma according to the CLSI guideline EP5-A2 "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-200 Edition":
| Plasma | Mean FVIII
activity, % | % CV, Within-run
(S-r) | % CV, Lot-to-Lot
(S-lot) | % CV, Within-
Device
(S-device) |
|---------------------------------------------------|---------------------------|---------------------------|-----------------------------|---------------------------------------|
| System N
(Normal Control
Plasma)
n=240 | 91.6% | 4.2% | 0.63% | 6.8% |
| System P
(Abnormal Control
Plasma)
n=240 | 33.3% | 4.9% | 3.8% | 8.0% |
| Low FVIII pooled
patient plasma
n=120 | 11.8% | 5.7% | 0.0% | 8.5% |
NoFact VIII Deficient Plasma provided acceptable precision.
NoFact VIII Deficient Plasma is substantially equivalent to Stago VIII Deficient Plasma.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
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 Drive. South Bend, IN 46628
DEC 1 9 2011
Re: K102851
Trade/Device Name: NoFact VIII 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
4
Page 2 - Mr. Marc D. Goldford
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/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
$f_{oh}$
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): K102851
Device Name: NoFact VIII Deficient Plasma
Indications For Use: NoFact VIII Deficient Plasma is a human plasma immunodepleted of Factor VIII and intended for the quantitative determination of Factor VIII activity in citrated plasma from patients suspected of FVIII deficiency. FVIII 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) K102851