(146 days)
Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, 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. Factor VIII is human plasma and bovine material.
Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XI, XII, respectively, utilized in in vitro diagnostic use.
The provided document is a summary of safety and effectiveness for Factor Deficient Coagulation Plasma, intended for use in determining specific factor levels in patients.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria with corresponding performance data in the typical sense of accuracy, sensitivity, or specificity. Instead, it focuses on attributes and features that are compared to predicate devices, inferring that meeting these attributes constitutes acceptable performance. The "Performance Testing" section outlines criteria related to safety and functionality.
| Acceptance Criteria (Inferred from "Performance Testing" and "Donor Criteria") | Reported Device Performance (Intended Products) |
|---|---|
| Compare assay to known sample | Yes |
| Negative by FDA approved test for HIV 1/2 and HBsAg | Yes |
| Negative by FDA approved test for HCV and HIV-1ag | Yes |
| Deficiency of relevant factor less than 1% | Yes |
| Negative for HIV and HBsAg | Yes |
| Negative for HCV, HIV-1ag | Yes |
| No inhibitor present | Yes |
| Indicated for use in determination of coagulation of plasma | Yes |
| In vitro diagnostic use | Yes |
| Used as a quantitative assay | Yes |
| Factor deficient plasmas offered - II, V, VII, VIII, IX, X, XI, XII | Yes |
| Packaging either - Frozen or Dry / lyophilized | Yes |
| Can be used with different instruments and reagents per manufacturer instructions | Yes |
| Donor human plasma material | Yes |
| Bovine enhanced factor VIII material | Yes |
| Various buffers used in materials | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "known samples" for assay comparison but provides no details on their number or characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human reader improvement with or without AI assistance. This is expected as the device is a reagent, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study in the context of an algorithm. This is not applicable as the device is a reagent for in-vitro diagnostic use, not an algorithm. Performance is assessed through its functional characteristics in laboratory tests.
7. Type of Ground Truth Used
The type of ground truth can be inferred from the "Performance Testing" section:
- Comparison to known samples: This suggests that the ground truth for some performance aspects (e.g., accuracy of coagulation determination) was based on pre-established values or characteristics of control samples.
- Negative by FDA approved tests for specific viruses and contaminants: The ground truth for safety aspects (e.g., HIV, HBsAg, HCV) was based on results from validated FDA-approved diagnostic tests.
- Deficiency of relevant factor less than 1% and no inhibitor present: The ground truth for the purity and specificity of the deficient plasma was likely established through quantitative laboratory assays designed to measure factor levels and detect inhibitors.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This concept is typically relevant for machine learning algorithms, which is not what this device is.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
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Image /page/0/Picture/0 description: The image is a black and white drawing of a world map. The map is drawn in a unique projection, where the continents are stretched and distorted. The map is also overlaid with a grid of lines, which may represent latitude and longitude. The continents of North America, South America, Africa, Europe, Asia, and Australia are all visible in the image.
UNIVERSAL REAGENTS, INC.
2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
OCT 1 0 1996
Non-Confidential Summary of Safety and Effectiveness
May 15, 1996
page 1 of 3
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 - II, V, VII, VIII, IX, X, XI, XII | ||
| Common/Usual Name: | Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII | ||
| Classification Name: | Factor deficient coagulation plasma | ||
| Intended device: | Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII | ||
| Predicate devices: | Behring Factor Deficient Plasmas -K924394 - Factor V, K924396 - Factor VIII, IX, XI, XIIK924400 - Factor II, VII, X | ||
| and | |||
| Medical Diagnostics Technologies -K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII,K893533 - Factor V, K893534 - Factor XII, K893535 - Factor VII,K893536 - Factor XI, K900133 - Factor II. | |||
| Device description: | Factor deficient plasma to be free of antigen of Factor II, V, VII,VIII, IX, X, XI, XII, respectively, utilized in in vitro diagnostic use. | ||
| Intended use |
Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, XI, XII, XII, 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. Factor VIII is human plasma and bovine material.
Environment of use - Hospital, laboratories
page 3 of 25
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Non-Confidential Summary of Safety and Effectiveness (continued)
May 15, 1996
page 2 of 3
Comparison to predicate devices: (continued)
| Attribute | Intendedproducts | Behring | Medical DiagnosticsTechnologies |
|---|---|---|---|
| Use | |||
| Indicated for use in determinationof coagulation of plasma | Yes | Yes | Yes |
| In vitro diagnostic use | Yes | Yes | Yes |
| Used as a quantitative assay | Yes | Yes | Yes |
| Design | |||
| Factor deficient plasmas offered -II, V, VII, VIII, IX, X, XI, XII | Yes | Yes | Yes |
| Packaging either -Frozen or Dry / lyophilized | Yes | Yes | Yes |
| Can be used with differentinstruments and reagents permanufacturer instructions | Yes | Yes | Yes |
| Materials | |||
| Donor human plasma | Yes | Yes | Yes |
| Bovine enhanced factor VIII | Yes | Yes | Yes |
| Various buffers | Yes | Yes | Yes |
| Performance Testing | |||
| Compare assay to known sample | Yes | Yes | Yes |
| Negative by FDA approved test forHIV 1/2 and HBsAG | Yes | Yes | Yes |
page 4 of 25
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Non-Confidential Summary of Safety and Effectiveness (continued)
May 15, 1996
page 3 of 3
Comparison to predicate devices: (continued)
| Attribute | Intendedproducts | Behring | Medical DiagnosticTechnologies |
|---|---|---|---|
| Performance Testing (continued) | |||
| Negative by FDA approved test forHCV and HIV-1ag | Yes | not known | not known |
| Donor criteria | |||
| Deficiency of relevant factorless than 1% | Yes | not known | Yes |
| Negative for HIV and HBSAG | Yes | Yes | Yes |
| Negative for HCV, HIV-1ag | Yes | not known | not known |
| No inhibitor present | Yes | not known | Yes |
B. Differences
(
The only difference is that the intended products are claimed to be negative for HCV and HIV-1ag by an FDA approved test.
Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.
page 5 of 25
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§ 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).