K Number
K970607
Device Name
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
Date Cleared
1997-04-25

(66 days)

Product Code
Regulation Number
864.7290
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Device Description
Factor deficient coagulation plasma - VII is a human plasma immunodepleted of the specific factor and intended for use in in vitro diagnostic use.
More Information

Not Found

No
The summary describes a plasma-based in vitro diagnostic device for measuring coagulation factor levels, with no mention of AI or ML in the intended use, device description, or performance studies.

No
The device is described as for "in vitro diagnostic use" and "intended for use in the quantitative determination of the specific factor levels," not for treating a condition or disease.

Yes
The "Intended Use / Indications for Use" states that the product is "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," which is a diagnostic purpose. The "Device Description" also specifies "in vitro diagnostic use."

No

The device description clearly states it is "human plasma immunodepleted of the specific factor," indicating it is a biological product, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's for 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." This is a diagnostic purpose performed in vitro (outside the body).
  • Device Description: The device description also explicitly states it's "intended for use in in vitro diagnostic use."
  • Clinical Laboratories: The intended user is "Clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
  • Performance Studies: The summary of performance studies describes testing the assay against known samples and ensuring the deficiency of the relevant factor is low, which are relevant to the performance of a diagnostic test.
  • Predicate Device: The presence of a predicate device (K883692 - Factor VII Factor deficient plasma) further indicates that this type of product is regulated as an IVD.

All these points strongly support the classification of this device as an In Vitro Diagnostic.

N/A

Intended Use / Indications for 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.

Product codes

Not Found

Device Description

Factor deficient plasma to be free of antigen of Factor VII utilized in 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

Clinical laboratories

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Compare assay to known sample.
Negative by FDA approved test for HIV 1/2 and HBsAG.
Negative by FDA approved test for HCV and HIV-1ag.
Deficiency of relevant factor less than 1%.
Negative for HIV and HBsAG.
Negative for HCV, HIV-1ag.
No inhibitor present.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K883692

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014

K970607)

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:

AttributeIntended productOrtho
Use
Indicated for use in determination
of coagulation of plasmaYesYes
In vitro diagnostic useYesYes
Used as a quantitative assayYesYes
Design
Factor VII deficient plasma offeredYesYes

1

Non-Confidential Summary of Safety and Effectiveness (continued)

February 17, 1997

page 2 of 2

Comparison to predicate devices: (continued)

| Attribute | Intended
products | Ortho |
|-----------------------------------------------------------------------------------------|----------------------|-----------|
| Packaging either -
Frozen or Dry / lyophilized | Yes | Yes |
| Can be used with different
instruments and reagents per
manufacturer 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 for
HIV 1/2 and HBsAG | Yes | Yes |
| Negative by FDA approved test for
HCV and HIV-1ag | Yes | not known |
| Deficiency of relevant factor
less 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.