SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR

K962762 · Biotraces, Inc. · JJJ · Aug 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962762
• Device Name: SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
• Applicant: Biotraces, Inc.
• Product Code: JJJ · Clinical Chemistry
• Decision Date: Aug 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2320
• Device Class: Class 1

Intended Use

The ssMPD is intended as a general use clinical laboratory gamma radiation counter. The ssMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).

Device Story

Bench-top gamma radiation counter; measures gamma emissions from radiolabelled reagents (e.g., 125I) in sample tubes (0.05–2.0 mL). System uses twin CaF2(Eu) scintillator crystals coupled to high-resolution planar photomultiplier tubes (PMTs) to detect radiation. Input signals processed via hardware and software for pulse shape/height analysis to calculate counts per minute (cpm) and disintegrations per minute (dpm). System includes lead-tin-copper shielding to reduce background noise. Operated by qualified laboratory personnel in clinical settings. Data output via connected PC running MPDATA control/logger software. Results used by clinicians to quantify radioassay/radioimmunoassay diagnostic tests.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Twelve-sample bench-top gamma counter. Detectors: twin CaF2(Eu) scintillator crystals with bialkali photocathode PMTs. Shielding: composite lead-tin-copper. Connectivity: direct connection to PC. Software: MPDATA control and data logger. Dimensions: accommodates 12mm x 75mm or 13mm x 100mm tubes. Energy measurement: pulse shape and pulse height analysis.

Indications for Use

Indicated for use by qualified clinical laboratory operators to measure gamma-ray emissions from radiolabelled reagents in diagnostic radioassay or radioimmunoassay methods.

Regulatory Classification

Identification

A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.

Predicate Devices

• Gamma 5500 Counting System (K770088)

Submission Summary (Full Text)

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AUG 16 1996
K962762

# IX. SAFETY AND EFFECTIVENESS SUMMARY

BioTraces Inc.
10517-A West Drive
Fairfax, VA 22030

Office: tel: [phone]
fax: [phone]

## Premarket Notification [510(k)] Summary

| Summary submitted by: | E. James Wadiak, President |
| --- | --- |
| Address: | BIOTRACES INC., 10517-A West Drive, Fairfax, VA, 22030 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact person: | E. James Wadiak, President |
| Summary prepared on: | July 8, 1996 |
| Proprietary Name: | SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (SSMPD) |
| --- | --- |
| Common/Usual Name: | Gamma Scintillation Counter |
| Classification Name: | Counter (Beta, Gamma) For Clinical Use |
| Substantial Equivalence: | The SSMPD is substantially equivalent in specifications and principles of operation to the Gamma 5500 Counting System (originally listed as Gamma 4000 Scintillation Counter), 510(k) Number: K770088, manufactured by Beckman Instruments, Inc., Scientific Instruments Division, Irvine, California 92713. |
| --- | --- |
| Description: | The SSMPD is a twelve sample, bench-top gamma radiation counter that can be used to measure counts per minute and calculate disintegrations per minute emitted by multi-photon emission isotopes, including $^{125}\mathrm{I}$. In volumes of 0.05 to 2.0 mls contained in $12\mathrm{mm} \times 75\mathrm{mm}$ or $13\mathrm{mm} \times 100\mathrm{mm}$ sample tubes disintegrations are measured over the range of 1 to $10^{6}$ dpm. The sample tubes must be capped to minimize the possibility of contaminating the detector chamber. |
| --- | --- |

The full detector assembly is a twin detector system consisting of two scintillator crystals--each coupled to a high resolution planar photomultiplier. The entire detector is encased in a

Section IX - 1

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composite lead-tin-copper shield to minimize environmental background. In addition to permitting efficient counting of gamma emitters, the sample holder acts as a separator to reduce crosstalk within the twin scintillator detector assembly.

The complete ssMPD system is comprised of a standalone ssMPD connected directly to a personal computer (PC) configured with ssMPD read-out electronics, $\mathrm{MPDATA}^{\mathrm{TM}}$ control and data logger software, and optionally, a printer.

## Intended Use:

The ssMPD is intended as a general use clinical laboratory gamma radiation counter. The ssMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).

## Device Comparison:

Both the ssMPD and the Gamma 5500 Counting System utilize a $2^{\circ}$ inorganic scintillating crystal, a photomultiplier tube (PMT), various electronic systems to amplify, scale, and analyze pulse heights, and a variety of output formats and devices for display of results to quantify gamma emissions in a sample.

However, the ssMPD uses two identical $\mathrm{CaF}_2(\mathrm{Eu})$ scintillator crystals with PMT read-outs as a detector whereas the Gamma 5500 Counting System uses one NaI(Tl) scintillator crystal with PMT read-out. Both inorganic scintillator crystals have emission maximums that are well matched to the sensitivity of the bialkali photocathode PMTs used in the ssMPD and a refractive index that is close to that of most PMT windows and optical coupling compounds. The photoelectron yield of NaI(Tl) produces the highest signal of all known scintillators and is twice that of $\mathrm{CaF}_2(\mathrm{Eu})$. However, the light yield of $\mathrm{CaF}_2(\mathrm{Eu})$ is easily within an acceptable range of performance.

NaI(Tl) is susceptible to mechanical, thermal, and radiation damage. It is hydroscopic and colors over time and must be housed in a sealed environment. It is toxic. In addition, it is soft and cannot be machined easily. $\mathrm{CaF}_2(\mathrm{Eu})$ is not

Section IX - 2

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susceptible to mechanical, thermal, and radiation damage is transparent and insoluble in water and most solvents, permitting radioactive samples in solutions placed in direct contact with the crystal. It is non-addition, it is hard and can be machined easily.

The SSMPD performs pulse shape as well as pulse analysis in software and hardware to increase the speed of pulse acceptance and rejection and lower the environmental background. The Gamma 5500 Counting System uses pulse height analysis.

The SSMPD uses a 2" primary lead shield and a second composite lead-tin-copper shield to minimize backbelt events contributed by the lead itself. The Gamma Counting System utilizes 1" of lead shielding to secondary composite shield.

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