(49 days)
Not Found
No
The device is a set of calibrators, which are chemical solutions used to calibrate laboratory instruments. The description focuses on the composition, packaging, and performance characteristics (precision, linearity, comparison) of these solutions. There is no mention of any computational or algorithmic components, let alone AI or ML.
No
This device is an in-vitro diagnostic calibrator used to provide calibration points for electrodes on laboratory instruments. It is not intended for the treatment or diagnosis of disease in a living organism, but rather for analytical purposes in a lab setting.
Yes
The "Intended Use / Indications for Use" section explicitly states that the calibrators "are intended for in-vitro diagnostics use."
No
The device description clearly states that the device consists of buffered solutions packaged in foil bags, plastic bottles, and glass ampules. These are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the calibrators are "intended for in-vitro diagnostics use".
- Function: The device provides calibration points for electrodes used to measure analytes (Na+, K+, and Cl-) in human serum and urine. This is a fundamental function of an IVD, as it is used in vitro (outside the body) to analyze biological samples for diagnostic purposes.
- Device Description: The description details the composition and packaging of the calibrators, which are reagents used in laboratory testing.
- Performance Studies: The document includes summaries of analytical tests (Precision, Linearity, Comparison Studies) which are standard performance evaluations for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K040958) indicates that this device is being compared to a previously cleared IVD device, a common practice in regulatory submissions for IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Diamond Tokyo Boeki Calibrators are intended to serve as a direct replacement to Tokyo Boeki ISE Calibrators. Diamond Tokyo Boeki ISE Module calibrators are intended to provide calibration points for the Na*, K*, and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, Sapphire 400, Sirrus, TMS-1024i, TRX-7010 and Labmax 240 instruments in both Human Serum and Human Urine modes.
Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na', K', and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Diamond Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 420 ml of solution.
Diamond Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 20 ml of solution.
Diamond Urine Calibrator is comprised of Urine Calibrator 1 and 2 which are not sold separately. Each box contains 10 ampules of Calibrator 1 in a tray and 10 ampules of Calibrator 2 in a separate tray.
Diamond Urine Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.
Diamond Urine Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.
Each calibrator is comprised of the following concentrations of analytes,
| PN | ISE Module Calibrator | mmol/L | ||
|---|---|---|---|---|
| TB-20270477D | Calibrator 1 | 140 ± 2.0 | 4.00 ± 0.05 | 100 + 2 |
| TB-20270478D | Calibrator 2 | 160 ± 2.0 | 6.0 ± 0.05 | 120 + 2 |
| PN | ISE Module Calibrator | Na+
mmol/L | K+
mmol/L | Cl-
mmol/L |
|---|---|---|---|---|
| TB-20270480D | Urine Calibrator 1-2 | | | |
| TB-20270480AD | Urine Calibrator 1 | $10 \pm 0.5$ | $1.50 \pm 0.03$ | $12 \pm 0.5$ |
| TB-20270480BD | Urine Calibrator 2 | $60 \pm 1.0$ | $25.0 \pm 1.0$ | $85 \pm 2$ |
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
Not Found
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)
Precision Study:
Three samples each of Serum and Urine were analyzed. The samples are near the low, mid and high point of reference ranges. Within Run precision was calculated from 20 consecutive samples run between calibrations. Run to Run precision was calculated for 5 consecutive samples run between calibrations.
- Serum Precision, Within Run:
Na+ K+ Cl- Low Mid High Low Mid High Low Mid High Mean 118.04 142.94 154.64 3.93 5.08 5.92 92.35 110.38 118.43 SD 0.57 0.98 0.73 0.02 0.02 0.03 0.43 0.29 0.46 %CV 0.48 0.69 0.47 0.47 0.4 0.45 0.54 1.06 1.2 Spec
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
APR 1 7 2012
5. 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
. . . . . . .
| plicant: | Diamond Diagnostics Inc
333 Fiske Street
Holliston MA 01746 |
|------------------------|--------------------------------------------------------------------------------------------------|
| Contact Person: | Kathy Cruz
Quality Assurance Manager
Phone: (508) 429-0450 ext. 358
Fax: (508) 429-0452 |
| Date Prepared: | January 26, 2012 |
| Classification Name: | Calibrator, secondary |
| Trade Name: | Diamond Calibrators for Tokyo Boeki ISE Modules |
| Device Classification: | 21 CFR 862.1150 |
| Device Class: | Class II |
| Classification Panel: | Clinical Chemistry |
| Product Code: | JIT |
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1
Intended Use:
Description of Device:
Diamond Tokyo Boeki Calibrators are intended to serve as a direct replacement to Tokyo Boeki ISE Calibrators. Diamond Tokyo Boeki ISE Module calibrators are intended to provide calibration points for the Na*, K*, and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, Sapphire 400, Sirrus, TMS-1024i, TRX-7010 and Labmax 240 instruments in both Human Serum and Human Urine modes.
Diamond Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a foil bag with a draw tube and covered in a corrugated box. Each foil bag contains 420 ml of solution.
Diamond Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in a plastic bottle with a cap. Each plastic bottle contains 20 ml of solution.
Diamond Urine Calibrator is comprised of Urine Calibrator 1 and 2 which are not sold separately. Each box contains 10 ampules of Calibrator 1 in a tray and 10 ampules of Calibrator 2 in a separate tray.
Diamond Urine Calibrator 1 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.
Diamond Urine Calibrator 2 consists of a buffered solution of electrolytes and preservative. It contains no human or biological materials. It is packaged in glass ampule. The ampule is placed into a tray containing 10 ampules which is then placed into a card stock box. Each ampule contains 1.8 ml of solution.
Each calibrator is comprised of the following concentrations of analytes,
| PN | ISE Module Calibrator | mmol/L | ||
|---|---|---|---|---|
| TB-20270477D | Calibrator 1 | 140 ± 2.0 | 4.00 ± 0.05 | 100 + 2 |
| TB-20270478D | Calibrator 2 | 160 ± 2.0 | 6.0 ± 0.05 | 120 + 2 |
| PN | ISE Module Calibrator | Na+
mmol/L | K+
mmol/L | Cl-
mmol/L |
|---------------|-----------------------|---------------|-----------------|---------------|
| TB-20270480D | Urine Calibrator 1-2 | | | |
| TB-20270480AD | Urine Calibrator 1 | $10 \pm 0.5$ | $1.50 \pm 0.03$ | $12 \pm 0.5$ |
| TB-20270480BD | Urine Calibrator 2 | $60 \pm 1.0$ | $25.0 \pm 1.0$ | $85 \pm 2$ |
2
Predicate 510(k) number(s):
-
mparison with predicate:
| Characteristics | Diamond Calibrators for Tokyo Boeki ISE
Module | Tokyo Boeki ISE Module Calibrators |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device | New | Predicate |
| 510(k) Number | | K040958 |
| PN | TB-20270477D
TB-20270478D
TB-20270480D | 20-27-0477
20-27-0478
20-27-0480 |
| Product Type | Calibrators | same |
| Intended Use | For in-vitro diagnostics use to provide
calibration points for the Na+, K+, and Cl-
electrodes on the Tokyo Boeki Prestige 24i,
Biolis 24i, MGC 240, Sapphire 400, Sirrus,
TMS-1024i, TRX-7010 and Labmax 240
instruments having an ISE Module | same |
| Matrix | Buffered solution of salts & preservatives
Contains NO human or animal materials. | same |
| Packaging | Foil Bag, Plastic bottle, Glass Ampule | same |
| Color | Clear solution | same |
| Storage | 18-25°C | same |
| Shelf Life for TB-
20270477D | 24 months | same |
| Shelf Life for TB-
20270478D | 24 months | same |
| Shelf Life for TB-
20270480D | 24 months | same |
Summary of Analytical Tests:
- a. Precision
Three samples each of Serum and Urine were analyzed. The samples are near the low, mid and high point of reference ranges. Within Run precision was calculated from 20 consecutive samples run between calibrations. Run to Run precision was calculated for 5 consecutive samples run between calibrations.
| Na+ | K+ | Cl- | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Low | Mid | High | Low | Mid | High | Low | Mid | High | |
| Mean | 118.04 | 142.94 | 154.64 | 3.93 | 5.08 | 5.92 | 92.35 | 110.38 | 118.43 |
| SD | 0.57 | 0.98 | 0.73 | 0.02 | 0.02 | 0.03 | 0.43 | 0.29 | 0.46 |
| %CV | 0.48 | 0.69 | 0.47 | 0.47 | 0.4 | 0.45 | 0.54 | 1.06 | 1.2 |
| Spec | Linearity was evaluated by preparing stock solution with high concentrations of Na*, K*, and Cl in serum and urine. The stock solutions were dilutions) to concentrations across the measuring range of each analyte and matrix. Linear regression was performed on results of all test points using expected values calculated based on stocks sample dilution. Results are shown below. |
Serum Linearity Results
| Na+ | K+ | Cl+ | |
|---|---|---|---|
| Range | 70-200 | 1-20 | 70-200 |
| y-Intercept | -12.8 | -0.04 | 5.39 |
| m | 1.04 | 1.01 | 0.97 |
| R2 | 1.00 | 1.00 | 1.00 |
| Standard Error | 3.5 | 0.3 | 2.1 |
| Observations | 39 | 66 | 39 |
Urine Linearity Results
| Nat | Kt | Cit | |
|---|---|---|---|
| Range | -10-200 --- | - - 1-100 - - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| y-Intercept | .1.11 | 0.15 | - -0.26 |
| m | 1.01 | 1.02 | 1.02 |
| R2 | 0.99 | 1.00 | 1.00 |
| Standard Error | ર રે | 0.9 | 2.7 |
| Observations | 33 | દવે | રેજે |
c. Comparison Studies:
Comparison studies were conducted using Diamond Tokyo Boeki ISE Module Calibrators and the predicate Tokyo Boeki ISE Module Calibrators on the Biolis 24i. Samples of both matrices, serum and urine, which spanned the reportable range was used. The results are summarized below.
4
| Serum Correlation Results | |||
|---|---|---|---|
| Na+ | K+ | Cl+ | |
| Range | 70-200 | 1-20 | 70-200 |
| y-Intercept | -1.6 | 0.49 | 2.87 |
| m | 1.00 | 1.01 | 0.96 |
| R2 | 0.9969 | 0.9971 | 0.9955 |
| Standard Error | 2.5 | 0.3 | 2.6 |
| Observations | 33 | 57 | 39 |
| Urine Correlation Results | |||
|---|---|---|---|
| Na+ | K+ | Cl+ | |
| Range | 10-200 | 1-100 | 10-200 |
| y-Intercept | -1.3 | 0.44 | 2.65 |
| m | 0.99 | 0.98 | 0.96 |
| R2 | 0.9976 | 0.9998 | 0.9939 |
| Standard Error | 2.7 | 0.4 | 3.7 |
| Observations | 42 | 62 | 73 |
Stability: ರ.
Accelerated (high temperature) stress test was conducted to support stability claim. Heat stressed reagents showed that calibrator parameters remained within specification thereby demonstrating stability equivalent to Tokyo Boeki calibrators.
Traceability:
All testing for analytes were conducted using Standards prepared from NIST salts. Testing was also conducted using reference methods.
| Analyte | Standard Used for
Determination of Analyte Value | Instrument Used |
|---------|-----------------------------------------------------|-----------------------------------------------------|
| Na, K, | NIST 919a, 918a | IL 943 (Flame Photometry) |
| Cl | NIST 919a | Corning 925, SAT-500 Salt Analyzer
(Titrimetric) |
.
Expected Values (Controls, Calibrators, or Methods),
Target values, (or specifications) were obtained by testing reagents analytically prior to bottling if necessary to meet specifications, testing analytically during the bottling process and prior to release to stock for distribution.
のお気になる。
Conclusion:
:
Based on the results submitted in this pre market notification Diamond Tokyo Boeki ISE Module Calibrators are substantially equivalent to the Tokyo Boeki ISE Module Calibrators in Composition, Intended use, Packaging, and Storage for the measurement of Na*, K*, and CI .
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head in profile, with three faces nested within each other. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Diamond Diagnostics Inc Ms. Kathy Cruz Manager, Ouality Assurance Diamond Diagnostics Inc (USA) 333 Fiske Street Holliston, MA 01746
10903 New Hampshire Avenue Silver Spring, MD 20993
APR 1 7 2012
Re: K120591
Trade/Device Name: Diamond Calibrators for Tokyo Boeki ISE Module Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: February 24, 2012
Received: February 28, 2012
Dear Ms. Cruz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 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.
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
V.
Gary H. Lai, Ph.D.
Counney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
4. Indications for Use
510(k) Number (if known): _
Device Name: Diamond Calibrators for Tokyo Boeki ISE Module Calibrators
Indications for Use:
Diamond Calibrators for Tokyo Boeki ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na', K', and Cl electrodes on the Tokyo Boeki Prestige 24i, Biolis 24i, MGC 240, and Sirrus instruments in both Human Serum and Human Urine modes.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature of Witness
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120591