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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Diamond Calibrators for Medica ISE Module, based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for these calibrators revolve around their ability to provide accurate calibration points for Na+, K+, and Cl- electrodes, effectively performing equivalently to the predicate device. The values for Calibrant A and B are explicitly stated:

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

Reported Device Performance:
The summary states: "Results show equivalent performance for Na+, K+, and Cl calibration and precision. The devices show good correlation." This indicates that the Diamond Calibrators met the objective of providing calibration points within acceptable limits and demonstrating similar precision to the predicate device. While specific measured values are not provided in this summary, the declaration of "equivalent performance" and "good correlation" implies that the new device's output falls within the expected ranges and performs comparably to the predicate.

Study Details:

Based on the provided text, the study conducted is focused on demonstrating substantial equivalence to an existing predicate device rather than an independent standalone performance study or a comparative effectiveness study with human readers.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "Calibrators for Medica ISE Module were tested side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This implies multiple test runs or samples, but the exact number is not quantified.
- Data Provenance: Not explicitly stated. However, given it's a 510(k) submission from a US company (Holliston, MA), it's highly likely the testing was conducted in the US. The time frame (October 2009 submission) suggests prospective testing for this specific submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided as this is a chemical calibrator, not an imaging or diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for calibrators is their known chemical composition and the accuracy of the measurements they enable on an instrument.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable and not provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for a chemical calibrator. The performance here is objectively measured by the instrument.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for a chemical calibrator. The device described is not an AI-assisted diagnostic tool that aids human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done in the context of AI. However, the study essentially functions as an instrument-based standalone performance study for the calibrators. The "algorithm" here is the chemical process and the instrument's measurement system. The calibrators themselves were tested "side by side with the predicate device on the Poly-Chem Dallrona Galleralyzer and Randox Daytona instruments." This represents the performance of the calibrators as measured by the instrument, without human intervention in the measurement process itself, beyond operating the analyzer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the calibrators is their certified chemical concentrations (e.g., $140 \pm 2.0$ mmol/L for Na+ in Calibrant A). These are established through precise manufacturing and analytical chemistry methods. The "ground truth" during the comparison study would be the expected values on the instruments when calibrated correctly, as confirmed by the predicate device's performance.
The sample size for the training set:
- This is not applicable and not provided. This device is a chemical calibrator, not a machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- This is not applicable as there is no "training set" for this type of device. The ground truth for the calibrators themselves is established through their precise formulation and analytical verification during manufacturing.

Summary

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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 Inc333 Fiske StreetHolliston MA 01746
Contact Person:	Kathy CruzQuality Assurance ManagerPhone: (508) 429-0450 ext. 358Fax: (508) 429-0452	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:

PN	ISE Module Calibrator	Na+mmol/L	K+mmol/L	Cl-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 ISEModule	Medica ISE Module Calibrators
PN	ME-6370D, ME-5410D	006370-001, 5410
Product Type	Calibrator	Calibrator
Intended Use	For in-vitro diagnostics use to providecalibration points for the $Na^+$ , $K^+$ , and $Cl^-$electrodes on the Polymedco Poly-Chem,and Randox Daytona instruments havingthe Medica ISE Module	For in-vitro diagnostics use to providecalibration points for the $Na^+$ , $K^+$ , and$Cl^-$ electrodes on the Polymedco Poly-Chem, Randox Daytona, and MedicaEasy Electrolytes instruments havingthe Medica ISE Module
Matrix	Buffered solution of salts & preservativesContains NO human or animal materials.	Buffered solution of salts &preservativesContains NO human or animalmaterials.
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-6370DDiamond Medica ISE Module Calibrant A	006370-001Medica ISE Module Calibrant A
ME-5410DDiamond Medica ISE Module Calibrant B	5410Medica 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 providecalibration points for the Na+, K+, and Cl-electrodes on the Polymedco Poly-Chem,and Randox Daytona instruments havingthe Medica ISE Module	For in-vitro diagnostics use to providecalibration points for the Na+, K+, andCl- electrodes on the PolymedcoPoly-Chem, Randox Daytona, andMedica Easy Electrolytes instrumentshaving the Medica ISE Module
Matrix	Buffered solution of salts & preservativesContains NO human or animal materials.	Buffered solution of salts &preservativesContains NO human or animalmaterials.
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 (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/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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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:

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

Regulation Number and Section

§ 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.