(444 days)
No
The 510(k) summary describes an in vitro diagnostic reagent (deficient plasma) used in a standard coagulation assay (activated partial thromboplastin time) for measuring Factor IX activity. There is no mention of AI, ML, image processing, or any computational analysis beyond standard statistical methods for performance evaluation.
No
Explanation: The device is intended for in vitro diagnostic use to determine Factor IX activity, not for treating a condition.
Yes
Explanation: The "Intended Use/Indications for Use" explicitly states that the device is "intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency" and is "For in vitro diagnostic use." The "Device Description" reiterates this, confirming its role in diagnosing FIX deficiency by measuring Factor IX activity.
No
The device is a biological reagent (human plasma) used in an in vitro diagnostic test, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" and "Device Description" sections both clearly state: "For in vitro diagnostic use."
- Intended Use: The device is intended for the "quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency." This is a diagnostic test performed on a biological sample (plasma) outside of the body (in vitro).
- Method: The determination of FIX activity is based on the activated partial thromboplastin time, which is a common laboratory test.
These points definitively classify the device as an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
GJT
Device Description
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.
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 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 were analyzed. The linear regression equation of this comparison was: y = 0.858* x + 5.73, with a coefficient of determination of 0.915.
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".
Key results:
- Regression analysis:
- All Labs (N=233): Slope = 0.858, Intercept = 5.729, r2 = 0.915, r = 0.956
- Site 1 (N=100): Slope = 0.785, Intercept = 6.168, r2 = 0.977, r = 0.988
- Site 2 (N=80): Slope = 0.923, Intercept = 5.328, r2 = 0.907, r = 0.988
- Site 3 (N=53): Slope = 0.817, Intercept = 11.206, r2 = 0.830, r = 0.911
- Precision:
- System N (Normal Control Plasma) N=240, Mean FIX activity = 109%: % CV, Within-run (S-r) = 5.1%, % CV, Lot-to-Lot (S-lot) = 1.1%, % CV, Within-Device (S-device) = 7.2%
- System P (Abnormal Control Plasma) N=240, Mean FIX activity = 43%: % CV, Within-run (S-r) = 4.6%, % CV, Lot-to-Lot (S-lot) = 2.9%, % CV, Within-Device (S-device) = 7.7%
- Low FIX pooled patient plasma N=120, Mean FIX activity = 14%: % CV, Within-run (S-r) = 5.7%, % CV, Lot-to-Lot (S-lot) = 2.2%, % CV, Within-Device (S-device) = 7.8%
Key Metrics
- Coefficient of determination (r2)
- r (correlation coefficient)
- Slope
- Intercept
- Percent Coefficient of Variation (%CV)
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: K102908.
1) Applicant Name and Address
| 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 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)
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.
5) Intended Use(s)
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.
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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 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. | STA Deficient IX is an | |
| immunodepleted human | ||
| plasma intended for use in tests | ||
| for the determination of factor | ||
| IX activity in plasma by | ||
| analyzers of the STA line | ||
| suitable with this reagent. | ||
| Constituent material | Citrated human plasma | |
| immunodepleted of Factor IX. | Citrated human plasma | |
| immunodepleted of Factor IX. | ||
| Measurement principle | Diluted patient sample is mixed | |
| with factor IX deficient plasma | ||
| and then tested with an APTT. | ||
| In these conditions the clotting | ||
| time of the mixture is | ||
| dependent on the | ||
| concentration of FIX in the | ||
| patient sample. | Diluted patient sample is mixed | |
| with factor IX deficient plasma | ||
| and then tested with an APTT. | ||
| In these conditions the clotting | ||
| time of the mixture is | ||
| dependent on the | ||
| concentration of FIX in the | ||
| patient 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 hr | |
| RT: 4 hr | 2-8C: not listed | |
| RT: not listed | ||
| On-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 FIX
activity, % | % CV, Within-run
(S-r) | % CV, Lot-to-Lot
(S-lot) | % CV, Within-
Device (S-
device) |
|---------------------------------------------------|-------------------------|---------------------------|-----------------------------|----------------------------------------|
| System N
(Normal Control
Plasma)
N=240 | 109% | 5.1% | 1.1% | 7.2% |
| System P
(Abnormal Control
Plasma)
N=240 | 43% | 4.6% | 2.9% | 7.7% |
| Low FIX pooled patient
plasma
N=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
4
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