(25 days)
This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.
Factor deficient plasma to be free of antigen of Factor XI utilized in in vitro diagnostic use. Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
This document describes the safety and effectiveness of the Factor Deficient Coagulation Plasma - XI, a device used for quantitative determination of Factor XI levels. The submission is a 510(k) premarket notification, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, statistically defined manner typically found in modern device submissions. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Pacific Hemostasis Factor XI) by comparing attributes and performance. The "performance testing" section outlines specific checks rather than performance targets.
| Acceptance Criterion (Implied/Predicate Attribute) | Reported Device Performance (Intended Product) |
|---|---|
| Use: Indicated for use in determination of coagulation of plasma | Yes |
| Use: In vitro diagnostic use | Yes |
| Use: Used as a quantitative assay | Yes |
| Design: Factor XI deficient plasma offered | Yes |
| Packaging: Frozen or Dry / lyophilized | Yes |
| Compatibility: Can be used with different instruments and reagents per manufacturer instructions | Yes |
| Materials: Donor human plasma | Yes |
| Materials: Various buffers | Yes |
| Performance Testing: Compare assay to known sample | Yes |
| Safety: Negative by FDA approved test for HIV 1/2 and HBsAG | Yes |
| Safety: Negative by FDA approved test for HCV and HIV-1ag | Yes |
| Deficiency: Deficiency of relevant factor less than 1% | Yes |
| Safety: Negative for HIV and HBsAG | Yes |
| Safety: Negative for HCV, HIV-1ag | Yes |
| Inhibitor: No inhibitor present | Yes |
Note on "Acceptance Criteria": For a 510(k) in 1997, the primary "acceptance criterion" was substantial equivalence to a predicate device. The performance characteristics listed above are the evidence presented to demonstrate that equivalence. There are no specific quantitative thresholds like "sensitivity > X%" or "specificity > Y%" mentioned, which are more common in contemporary submissions for higher-risk devices or those without clear predicates.
2. Sample Sizes and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document refers to "Performance Testing" which includes comparing the assay to a "known sample," but the number of such samples or tests performed is not quantified.
- Data Provenance: Not explicitly stated. Given the context of a diagnostic product submission, the testing would likely have been conducted in a laboratory setting. There's no information regarding the country of origin of the data, nor whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted to validate the product's characteristics.
3. Number of Experts and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method
- No adjudication method is described. This type of submission (for a laboratory reagent) typically relies on direct laboratory measurement outcomes rather than human expert interpretation needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic systems where human interpretation is a key component and AI provides assistance. The device in question is a laboratory reagent; its performance is measured biochemically.
6. Standalone Performance Study
- Yes, a form of standalone performance was implicitly done. The "Performance Testing" section describes characteristics of the intended product itself (e.g., deficiency of relevant factor less than 1%, negative for various viruses, no inhibitor present). The comparison with the predicate device also assesses the standalone performance of the new device against an established one. The results listed in the table are the device's standalone characteristics.
7. Type of Ground Truth Used
- The ground truth used for specific performance claims appears to be:
- "Known sample": For comparing assay performance, implying a reference standard or samples with known characteristics.
- "FDA approved test": For viral negativity claims (HIV 1/2, HBsAG, HCV, HIV-1ag), implying established and validated diagnostic tests as the ground truth.
- Analytical measurement: For "deficiency of relevant factor less than 1%" and "no inhibitor present," implying direct biochemical measurements against established analytical methods.
8. Sample Size for the Training Set
- Not applicable/Not mentioned. The device is a laboratory reagent (Factor XI deficient plasma) and not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process of immunodepleting plasma is a biochemical one, not an iterative learning process with data.
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not mentioned for the same reasons as in point 8.
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JUL 14 1997
Safety and Effectiveness Summary and Premarket Notification Truthful and Accurate Statement
Safety and effectiveness summary:
Section # 2
The Non-confidential Summary of Safety and Effectiveness follows.
Premarket Notification Truthful and Accurate Statement:
As recommended, this statement has been placed on company letterhead and follows.
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UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
- . . . .
Non-Confidential Summary of Safety and Effectiveness June 18, 1997 page 1 of 2
| Universal Reagents, Inc.2858 N. Pennsylvania St.Indianapolis, IN 46205 | Tel - (317) 926-0006Fax - (317) 926-0014 |
|---|---|
| Official contact: | Jorge Miller, Director, Coagulation Products |
| Proprietary or Trade Name: | Factor deficient coagulation plasma - XI |
| Common/Usual Name: | Qualitative and Quantitative Factor Deficiency Test - XI |
| Classification Name: | Qualitative and Quantitative Factor Deficiency Test |
| Intended device: | Factor deficient coagulation plasma - XI |
| Predicate devices: | Pacific Hemostasis Factor XI - K# unknown |
| Device description: | Factor deficient plasma to be free of antigen of Factor XIutilized in in vitro diagnostic use. |
Intended use:
Indicated use - Factor deficient plasma, Factor - XI 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 | Pacific Hemostasis |
|---|---|---|
| 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 XI deficient plasma offered | Yes | Yes |
| page 3 of 30 |
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Non-Confidential Summary of Safety and Effectiveness
June 18, 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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
JUL 1 4 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jorge Miller Director, Coagulation Products Universal Reagents, Inc..... ..... 2858 North Pennsylvania Street Indianapolis, Indiana 46205
K972286 Re : URI Factor XI Requlatory Class: II Product Code: GJT, GGP Dated: June 18, 1997 Received: June 19, 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 registration, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 Requlations.
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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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 one roganieren one instion" (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)
page 1 of 1
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 Plasma Factor - XI (11)
Indications for Use:
This product is intended for use in the quantitative determination of Indicated use factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI.
Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors.
Claims -Negative per FDA approved test for HIV 1/2, HBsAG, HCV, HIV-1ag · Packaging -Frozen
Freeze dried - Lyophilized
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices
510(k) Number 7-60-92
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
page 7 of 36
Section # 4
Section #
crons # 6,
ttachments
§ 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).