(66 days)
Indicated use - Factor deficient plasma, Factor - VII 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 deficient coagulation plasma - VII is a human plasma immunodepleted of the specific factor and intended for use in in vitro diagnostic use.
This document does not contain information about acceptance criteria, device performance, or a study that evaluates a device against acceptance criteria in the way described in the prompt. The document is a "Non-Confidential Summary of Safety and Effectiveness" for "Factor deficient coagulation plasma - VII." It primarily serves to compare the intended product with predicate devices.
Here's a breakdown of why the requested information cannot be extracted:
- No defined acceptance criteria: The document lists "Performance Testing" attributes, but these are general characteristics (e.g., "Compare assay to known sample," "Deficiency of relevant factor less than 1%") rather than specific, quantitative acceptance criteria with thresholds.
- No reported device performance against criteria: While it states "Yes" for the intended product meeting certain characteristics, it doesn't provide numerical or qualitative results from a study demonstrating performance against specific, pre-defined acceptance criteria.
- No study details: The document mentions "Performance Testing" but does not describe a study. There is no information on sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods. The "Performance Testing" section simply lists features the device will possess or is designed to meet, not the results of a test proving it.
- AI/Human-in-the-loop irrelevance: This document describes a diagnostic reagent, not an AI or imaging device, so questions related to MRMC studies, human reader improvement with AI, or standalone algorithm performance are not applicable.
Therefore, it is not possible to fill out the requested table and answer the study-related questions based on the provided text.
The document's purpose is to argue substantial equivalence to predicate devices, focusing on design features and intended use rather than presenting a performance study against acceptance criteria.
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UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014
PR 25 1997
Non-Confidential Summary of Safety and Effectiveness February 17, 1997 page 1 of 2
Universal Reagents, Inc. Tel - (317) 926-0006 Fax - (317) 926-0014 2858 N. Pennsylvania St. Indianapolis, IN 46205 Official contact: Jorge Miller, Director, Coagulation Products Proprietary or Trade Name: Factor deficient coagulation plasma - VII Common/Usual Name: Qualitative and Quantitative Factor Deficiency Test - VII Classification Name: Qualitative and Quantitative Factor Deficiency Test Intended device: Factor deficient coagulation plasma - VII Predicate devices: Ortho Diagnostic Systems - K883692 - Factor VII Factor deficient plasma to be free of antigen of Factor VII utilized Device description: in in vitro diagnostic use.
Intended use:
Indicated use - Factor deficient plasma, Factor - VII 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 | Ortho |
|---|---|---|
| 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 VII deficient plasma offered | Yes | Yes |
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Non-Confidential Summary of Safety and Effectiveness (continued)
February 17, 1997
page 2 of 2
Comparison to predicate devices: (continued)
| Attribute | Intendedproducts | Ortho |
|---|---|---|
| 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.
§ 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).