AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER by DAXOR CORPORATION

The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results.

The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

Device Description

The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Daxor BVA-100 Blood Volume Analyzer, indicating that it has been found substantially equivalent to a predicate device.

While it mentions the device's indications for use and general regulatory information, it does not include any specifics about:

Acceptance criteria or reported device performance.
Sample sizes, data provenance, or details about test sets.
Number or qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

To obtain this information, you would typically need to consult a comprehensive study report, a specific clinical trial publication, or the full 510(k) submission document (which often contains more detailed performance data than the clearance letter itself).

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ronald H. Baldry Vice President for Engineering Daxor Corporation 312 Trossachs Lane Knoxville, Tennessee

Re : K964406 Automated Multi-point Blood Volume Analyzer Requlatory Class: II Product Code: JWO Dated: July 3, 1997 Received: July 7, 1997

Dear Mr. Baldry:

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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation 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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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 diagnostic 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 premarket notification" (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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510(k) Number: : K964406

Device Name: Blood Volume Analyzer - BVA-100

Indications for Use:

The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K964406

ASE DO NOT WRITE BBLOW THIS LINE - CONTINUE ON ANOTHER. PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion Use
CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 864.5950 Blood volume measuring device.

(a)
Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.(b)
Classification. Class II (performance standards).