DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH

K121027 · Diamond Diagnostics, Inc. · JIT · Dec 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121027
• Device Name: DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Diamond Diagnostics Calibrators for ATAC 8000 and Envoy 500 instruments are intended to provide calibration points for the Na⁺, K⁺, Cl⁻ and CO₂ electrodes on the ATAC 8000 and Envoy 500 instruments. For prescription use only

Device Story

Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are aqueous buffered solutions containing electrolytes and preservatives in de-ionized water; no human or animal components. Provided as low and high-level liquid calibrators in 22ml amber vials. Used in clinical laboratory settings to calibrate Na⁺, K⁺, Cl⁻, and CO₂ electrodes on ATAC 8000 and Envoy 500 instruments. Value assignment performed gravimetrically and verified via flame photometry, titrimetric analysis, and comparative testing on clinical analyzers. Ensures accuracy of patient sample measurements by providing standardized reference points for ion-selective electrode (ISE) systems.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through gravimetric preparation, traceability to NIST standards (919a, 918a), and analytical testing on ATAC 8000 and Envoy 500 instruments to ensure target value specifications are met. Accelerated stability studies support a 24-month shelf life.

Technological Characteristics

Aqueous buffered solution of electrolytes and preservatives in de-ionized water. Contains no human or animal products. Packaged in 22ml amber glass vials. Shelf life of 24 months. Storage at 18-25°C. No electronic or software components.

Indications for Use

Indicated for use as calibration points for Na⁺, K⁺, Cl⁻, and CO₂ electrodes on ATAC 8000 and Envoy 500 clinical chemistry instruments.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• ATAC 8000/Envoy 500 ISE Calibrators (k945271)

Submission Summary (Full Text)

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## 5. 510(k) Summary

121027

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92

| Applicant: | Diamond Diagnostics Inc<br>333 Fiske Street<br>Holliston MA 01746 | | | | | DEC 2 0 2012 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------|---------------|---------------|--------------|
| Contact Person: | Kathy Cruz<br>Quality Assurance Manager<br>Phone: [phone] ext. 358<br>Fax: [phone] | | | | | |
| Date Prepared: | 10/25/2012 | | | | | |
| Classification Name: | Calibrator, secondary | | | | | |
| Trade Name: | Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators | | | | | |
| Device Classification: | 21 CFR 862.1150 | | | | | |
| Device Class: | Class II | | | | | |
| Classification Panel: | Clinical Chemistry | | | | | |
| Product Code: | JIT | | | | | |
| Intended Use: | Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators<br>are intended to provide calibration points for the Na+, K+, Cl-, and CO2<br>electrodes on the ATAC 8000 and Envoy 500 instruments. | | | | | |
| Description of Device: | Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are<br>intended to serve as a direct replacement to ATAC 8000/Envoy 500<br>ISE Calibrators. | | | | | |
| | Diamond Calibrator Low consists of an aqueous buffered solution of<br>electrolytes and preservative in De-ionized water. It contains NO<br>human or animal products. It is a liquid packaged in a 22ml screw top<br>amber vial. Each vial contains 20 ml of solution. | | | | | |
| | Diamond Calibrator High consists of an aqueous buffered solution of<br>electrolytes and preservative in De-ionized water. It contains NO<br>human or animal products. It is a liquid packaged in a 22ml screw top<br>amber vial. Each vial contains 20 ml of solution. | | | | | |
| | Each calibrator is comprised of the following concentrations of<br>analytes, | | | | | |
| PN | ISE<br>Calibrator | Na+<br>mmol/L | K+<br>mmol/L | Cl-<br>mmol/L | CO2<br>mmol/L | |

BT-6620943D

BT-6620944D

Low

High

12/18/2012

3.05 ± 0.05

10.2 ± 0.1

78 ± 2

126 ± 1

92 ± 2.0

162 ± 1.0

11 ± 1

34.5 ± 1

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Predicate Device:

Predicate 510(k) number(s): K945271

Comparison with predicate:

| Characteristics | Diamond ATAC 8000/Envoy 500 ISE<br>Calibrators | ATAC 8000 ISE<br>Calibrators |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Device | New | Predicate |
| 510(k) Number | K121027 | K945271 |
| PN | BT-6620943D ISE Low Calibrator<br>BT-6620944D ISE High Calibrator<br>BT-6620940D (Kit) | 347240 ISE Low<br>Calibrator<br>347240 ISE High<br>Calibrator<br>347-240 (Kit) |
| Product Type | Calibrators | same |
| Intended Use | For in-vitro diagnostics use to provide<br>calibration points for the Na+, K+, Cl-<br>and CO2 electrodes on the ATAC 8000<br>instrument having an ISE Module | same |
| Matrix | Aqueous buffered solution of salts &<br>preservatives in De-ionized water.<br>Contains NO human or animal<br>materials. | same |
| Packaging, Vial | Glass Vial | Same |
| Packaging, Product | Box Level, 2x20mL | 2x6x20mL |
| Storage | 18-25°C | same |
| Shelf Life for BT-<br>6620943D | 24 months | same |
| Shelf Life for BT-<br>620944D | 24 months | same |

## Stability:

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 ATAC 8000 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<br>Analyte Value | Instrument Used |
|---------|-----------------------------------------------------|------------------------------------------------------|
| Na, K | NIST 919a, 918a | IL 943 (Flame Photometry) |
| Cl | NIST 919a | Corning 925, SAT-500 Salt<br>Analyzer, (Titrimetric) |
| CO2 | NIST 351 | Hitachi 912, Olympus-Beckman<br>CX-7 |

## Expected Values (Controls, Calibrators, or Methods),

Target values, (or specifications) were obtained by testing reagents analytically prior to bottling, adjusting if necessary to meet specifications, testing analytically during the bottling process and prior to release to stock for distribution.

#### Conclusion:

Based on the results submitted in this pre market notification Diamond ATAC 8000 ISE Calibrators are substantially equivalent to the ATAC 8000 ISE Calibrators in Composition, Intended use, Packaging, and Storage for the measurement of Na *, K , CI , and CO2.

2

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines intersecting a horizontal bar. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

Diamond Diagnostics, Inc. c/o Kathy Cruz 333 Fiske Street Holliston, MA 01746

Re: k121027

Trade/Device Name: ATAC 8000/Envoy 500 ISE Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator . Regulatory Class: II Product Code: JIT Dated: October 25, 2012 Received: October 26, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Cruz

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carol C. Benson for

Courtney H. Lias Director. Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k121027

Device Name: Diamond Diagnostics ATAC 8000/ Envoy 500 ISE calibrators

Indications for Use:

Diamond Diagnostics Calibrators for ATAC 8000 and Envoy 500 instruments are intended to provide calibration points for the Nat, K+, Cli and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Louise Romankeyles

sion Sign-( Office of In Vitro Diagnostics and Radiological Health

510(k) k121027