The Daxor BVA-200® is an automated system that is used to measure/calculate the red cell mass (mL), plasma volume (mL) and total blood volume (mL), along with the related deviations from ideal values by amount (mL) and percentage (%) in adults. In addition, the Normalized Hematocrit (%) and Albumin Transudation Rate (%/min) are calculated. It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter and accessory convenience kit. The Daxor BVA-200 is intended to calculate human blood volumes by the method of tracer diffusion (Indicator dilution technique) with I-131 as the tracer after injection of I-131 Human Serum Albumin. The Daxor BVA-200 provides a Quantitative Assessment of total blood and plasma volumes using an automated system. Data inputs to the software come from the measured characteristics of patient venous whole blood samples collected in K3EDTA vacutainer tubes (hematocrit and tracer concentration) and tracer calibration standards. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes are reported, with statistics showing the quality of the results. For in vitro diagnostic use in a Clinical Laboratory setting and operated by laboratory technicians. Rx use only.
Device Story
Blood Volume Analyzer (200) measures total blood volume; utilizes indicator-dilution principle via injection of tracer; samples blood; analyzes tracer concentration to calculate volume. Used in clinical settings by trained personnel. Modifications include reorganized labeling, updated EMC/EMI specifications, revised linearity QC instructions, and new automated notifications. Device remains substantially equivalent to previously cleared version; fundamental scientific technology unchanged.
Clinical Evidence
No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification of modifications to the previously cleared device.
Technological Characteristics
System includes microprocessor, touchscreen, and gamma counter. Gamma detection uses CsI crystal and silicon photomultiplier with tungsten shielding. Connectivity via thumb drive/printer. Power: battery or mains. Form factor: rugged tablet computer in portable case. Software performs automated scintillation counting and volume calculations. Disposables: whole blood collection cartridges. Radiation levels <1 microcurie (exempt from NRC occupational monitoring).
Indications for Use
Indicated for blood volume measurement in patients requiring clinical assessment of blood volume status.
Regulatory Classification
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.
{0}
**FDA** U.S. FOOD & DRUG
ADMINISTRATION
# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
## I Background Information:
### A 510(k) Number
K261099
### B Applicant
Daxor Corporation
### C Proprietary and Established Names
Blood Volume Analyzer (200)
### D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JWO | Class II | 21 CFR 864.5950 - Blood Volume Measuring Device | HE - Hematology |
## II Review Summary:
This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable;
1. 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a pre-amendments device, a statement to this effect has been provided.)
2. 2. Submitter's statement that the **INDICATIONS FOR USE/INTENDED USE** of the modified device as described in its labeling **HAS NOT CHANGED** along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. 3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed. This change was for modifications to a cleared device.**
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
Labeling reorganized into four named Parts (I–IV) with modifications to the following: EMC/EMI specifications, immunity testing results, and interference distance requirements relocated, radiation language updated, revised linearity QC testing instructions, new Automated Notifications section added, and limitations section has been revised.
4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their pre-amendment) device.
K261099 - Page 2 of 2
