DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D

K093357 · Diamond Diagnostics, Inc. · JIT · Jun 24, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093357
• Device Name: DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na⁺, K⁺, and Cl⁻ electrodes on the Polymeco Poly-Chem, and Randox Daytona instruments having the Medica ISE Module.

Device Story

Diamond Calibrators for Medica ISE Modules are liquid, buffered salt solutions used to calibrate Na⁺, K⁺, and Cl⁻ electrodes on specific clinical chemistry analyzers (Polymeco Poly-Chem, Randox Daytona). Calibrant A (500 mL foil bag) and Calibrant B (125 mL plastic bottle) contain defined concentrations of sodium, potassium, and chloride ions. The device is used in a clinical laboratory setting by trained personnel. The healthcare provider uses the calibrators to establish reference points for the ISE module, ensuring accurate measurement of patient electrolyte samples. The device contains no human or biological materials.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (accelerated) and traceability to NIST standards (919a, 918a) were performed to validate the device.

Technological Characteristics

Buffered solution of electrolytes and preservatives; contains no human or biological materials. Form factor: 500 ml foil bag (Calibrant A) and 125 ml plastic bottle (Calibrant B). Storage: 18-25°C. Standalone chemical calibrator.

Indications for Use

Indicated for in-vitro diagnostic use to provide calibration points for Na⁺, K⁺, and Cl⁻ electrodes on Polymeco Poly-Chem and Randox Daytona instruments equipped with Medica ISE Modules. For prescription use.

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

• Medica ISE Module Calibrators (K070057)

Submission Summary (Full Text)

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K093357

# 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

| Applicant: | Diamond Diagnostics Inc<br>333 Fiske Street<br>Holliston MA 01746 | |
|------------------------|--------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Kathy Cruz<br>Quality Assurance Manager<br>Phone: [phone] ext. 358<br>Fax: [phone] | JUN 2 4 2010 |
| Date Prepared: | October 27, 2009 | |
| Controls: | | |
| Classification Name: | Calibrator, secondary | |
| Trade Name: | Calibrating Material, Calibrating Standards | |
| Device Classification: | 21 CFR 862.1150 | |
| Device Class: | Class II | |
| Classification Panel: | Clinical Chemistry | |
| Product Code: | JIT | |

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Intended Use:

Diamond Calibrators for Medica ISE Module are intended for in-vitro diagnostics use to provide calibration points for the Na*, K*, and Cl electrodes on the Polymedco Poly-Chem and Randox Daytona instruments having the Medica ISE Module.

Description of Device:

Diamond Calibrant A matrix 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 500 ml of solution.

Diamond Calibrant B matrix 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 125 ml of solution.

| PN | ISE Module Calibrator | Na+<br>mmol/L | K+<br>mmol/L | Cl-<br>mmol/L |
|----------|-----------------------|---------------|-----------------|---------------|
| ME-6370D | A | $140 \pm 2.0$ | $4.00 \pm 0.05$ | $125 \pm 2$ |
| ME-5410D | B | $70 \pm 1.5$ | $8.0 \pm 0.08$ | $41 \pm 1.5$ |

Predicate Device:

Medica ISE Module Calibrators

K070057

Predicate 510(k) number(s):

Comparison with predicate:

| Characteristics | Diamond Calibrators for Medica ISE<br>Module | Medica ISE Module Calibrators |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PN | ME-6370D, ME-5410D | 006370-001, 5410 |
| Product Type | Calibrator | Calibrator |
| Intended Use | For in-vitro diagnostics use to provide<br>calibration points for the $Na^+$ , $K^+$ , and $Cl^-$<br>electrodes on the Polymedco Poly-Chem,<br>and Randox Daytona instruments having<br>the Medica ISE Module | For in-vitro diagnostics use to provide<br>calibration points for the $Na^+$ , $K^+$ , and<br>$Cl^-$ electrodes on the Polymedco Poly-<br>Chem, Randox Daytona, and Medica<br>Easy Electrolytes instruments having<br>the Medica ISE Module |
| Matrix | Buffered solution of salts & preservatives<br>Contains NO human or animal materials. | Buffered solution of salts &<br>preservatives<br>Contains NO human or animal<br>materials. |
| Packaging | Plastic bottle, Foil Bag | Plastic bottle, Foil Bag |
| Color | Clear solution | Clear solution |
| Storage | 18-25°C | 18-25°C |
| Shelf Life for ME-6370D | 30 months | 36 Months |
| Shelf Life for ME-5410D | 28 months | 36 Months |

#### Executive Summary

Based on the results submitted in this pre market notification Diamond Medica ISE Module Calibrators claim substantial equivalence to the Medica ISE Module Calibrators in Composition, which is, Na ", Intended use, Packaging, and Storage.

Overage: Calibrators for Medica ISE Module were tested side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments. The Medica ISE Module is a component of this Analyzer. Results show equivalent performance for Na*, K*, and Cl calibration and precision. The devices show good correlation.

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# Substantial Equivalence Discussion

Diamond Diagnostics claims substantial equivalence to the predicate calibrators listed below:

| Diamond Diagnostics Product | Medica ISE Module Calibrators |
|---------------------------------------------------|---------------------------------------------|
| ME-6370D<br>Diamond Medica ISE Module Calibrant A | 006370-001<br>Medica ISE Module Calibrant A |
| ME-5410D<br>Diamond Medica ISE Module Calibrant B | 5410<br>Medica ISE Module Calibrant B |

#### Substantial Equivalence Table of Product PN's & Trade Names

Diamond Diagnostics claims substantial equivalence to the Medica ISE Module Calibrators for Composition, Intended use, Packaging, and Storage. .

The table below compares Diamond Diagnostics Calibrators to the Predicate.

# Comparison Tables of Characteristics – Diamond vs Medica – by product

| Characteristics | Diamond Medica ISE Module Calibrators | Medica ISE Module Calibrators |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PN | ME-6370D, ME-5410D | 006370-001, 5410 |
| Product Type | Calibrator | Calibrator |
| Intended Use | For in-vitro diagnostics use to provide<br>calibration points for the Na+, K+, and Cl-<br>electrodes on the Polymedco Poly-Chem,<br>and Randox Daytona instruments having<br>the Medica ISE Module | For in-vitro diagnostics use to provide<br>calibration points for the Na+, K+, and<br>Cl- electrodes on the Polymedco<br>Poly-Chem, Randox Daytona, and<br>Medica Easy Electrolytes instruments<br>having the Medica ISE Module |
| Matrix | Buffered solution of salts & preservatives<br>Contains NO human or animal materials. | Buffered solution of salts &<br>preservatives<br>Contains NO human or animal<br>materials. |
| Packaging | Plastic bottle, Foil Bag | Plastic bottle, Foil Bag |
| Color | Clear solution | Clear solution |
| Storage | 18-25°C | 18-25°C |
| Shelf Life for ME-6370D | 30 months | 36 months |
| Shelf Life for ME-5410D | 28 months | 36 months |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 2 4 2018

Re: k093357

Trade Name: Diamond Calibrators for Medica ISE Module Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: June 17, 2010 Received: June 18, 2010

#### 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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## 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 [phone]. 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 [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

4093351 510(k) Number (if known): J

Device Name: Diamond Calibrators for Medica ISE Module

Indications for Use:

Diamond Calibrators for Medica ISE Modules are intended for in-vitro diagnostics use to provide calibration points for the Na *, K , and Ci electrodes on the Poly-Chem and Randox Daytona instruments having the Medica ISE Module.

Prescription Use X (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

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k). K093357