Diamond Diagnostics ATAC 8000/Envoy 500 ISE calibrators are intended to provide calibration points for the Na+, K+, Cl-, and CO2 electrodes on the ATAC 8000 and Envoy 500 instruments.

Device Description

Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators are intended to serve as a direct replacement to ATAC 8000/Envoy 500 ISE Calibrators. Diamond Calibrator Low consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution. Diamond Calibrator High consists of an aqueous buffered solution of electrolytes and preservative in De-ionized water. It contains NO human or animal products. It is a liquid packaged in a 22ml screw top amber vial. Each vial contains 20 ml of solution.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device (calibrators) and does not contain information about studies proving the device meets acceptance criteria in the manner expected for diagnostic algorithms or imaging devices. The acceptance criteria and "device performance" in this context refer to the established concentration ranges for the analytes within the calibrator solutions. The "study" here is a stability test and analytical testing to verify the stated concentrations and demonstrate substantial equivalence, rather than a clinical performance study with patient data.

Here's the information extracted and formatted, with explanations for where certain requested details are not applicable to this type of device submission:

Acceptance Criteria and Reported Device Performance

Analyte	Acceptance Criteria (Target Value ± Standard Deviation)	Reported Device Performance (as stated in the 510(k) summary)
Low Calibrator
Na+ (mmol/L)	3.05 ± 0.05	Not explicitly stated as "reported performance" but this is the target/specification for the product.
K+ (mmol/L)	10.2 ± 0.1	Not explicitly stated as "reported performance" but this is the target/specification for the product.
Cl- (mmol/L)	78 ± 2	Not explicitly stated as "reported performance" but this is the target/specification for the product.
CO2 (mmol/L)	11 ± 1	Not explicitly stated as "reported performance" but this is the target/specification for the product.
High Calibrator
Na+ (mmol/L)	126 ± 1	Not explicitly stated as "reported performance" but this is the target/specification for the product.
K+ (mmol/L)	92 ± 2.0	Not explicitly stated as "reported performance" but this is the target/specification for the product.
Cl- (mmol/L)	162 ± 1.0	Not explicitly stated as "reported performance" but this is the target/specification for the product.
CO2 (mmol/L)	34.5 ± 1	Not explicitly stated as "reported performance" but this is the target/specification for the product.

Note on "Reported Device Performance": For calibrators, "performance" is typically defined by the accuracy and stability of the analyte concentrations within the specified ranges. The 510(k) summary states that "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." This implies that the device meets these target values as part of its manufacturing and quality control process. The stability study further supports that these values are maintained over time.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not explicitly state a "test set" sample size in terms of clinical subjects or a specific number of calibrator units tested.
- The "test" here involves analytical testing of the calibrator solutions themselves.
- Data provenance: Not specified in terms of country, but it's an in-vitro diagnostic device manufactured by Diamond Diagnostics Inc. in Holliston, MA. The testing is analytical, not clinical, so retrospective/prospective does not apply in the typical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. For a calibrator device, the "ground truth" for the analyte concentrations is established through analytical methods using NIST standards, not through expert human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. "Adjudication" typically refers to resolving disagreements among human readers in a clinical study. Here, the "truth" is determined by reference analytical methods.
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:
- Not applicable. This device is a calibrator, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The device itself is a standalone calibrator solution. Its "performance" is its ability to accurately provide known concentrations for instrument calibration.
- The "study" supporting this involved:
  - Stability testing: "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." This is a standalone performance test of the calibrator's chemical integrity over time.
  - Traceability and Analytical Testing: Analytes were determined using NIST standards (NIST 919a, 918a, 351). Instruments used for verification included IL 943 (Flame Photometry for Na, K), Corning 925, SAT-500 Salt Analyzer (Titrimetric for Cl), and Hitachi 912, Olympus-Beckman CX-7 (for CO2). This constitutes the direct analytical performance demonstration.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Standards / Analytical Methods: The ground truth for the analyte concentrations (Na+, K+, Cl-, CO2) was established using certified National Institute of Standards and Technology (NIST) reference materials and validated reference analytical methods (Flame Photometry, Titrimetry).
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm. The ground truth for the calibrator's analyte concentrations is established during its manufacturing and quality control process using NIST-traceable standards and analytical methods, as described in point 6.

Summary

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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 Inc333 Fiske StreetHolliston MA 01746
Contact Person:	Kathy CruzQuality Assurance ManagerPhone: (508) 429-0450 ext. 358Fax: (508) 429-0452
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 calibratorsare intended to provide calibration points for the Na+, K+, Cl-, and CO2electrodes on the ATAC 8000 and Envoy 500 instruments.
Description of Device:	Diamond Diagnostics ATAC 8000/Envoy 500 ISE Calibrators areintended to serve as a direct replacement to ATAC 8000/Envoy 500ISE Calibrators.
	Diamond Calibrator Low consists of an aqueous buffered solution ofelectrolytes and preservative in De-ionized water. It contains NOhuman or animal products. It is a liquid packaged in a 22ml screw topamber vial. Each vial contains 20 ml of solution.
	Diamond Calibrator High consists of an aqueous buffered solution ofelectrolytes and preservative in De-ionized water. It contains NOhuman or animal products. It is a liquid packaged in a 22ml screw topamber vial. Each vial contains 20 ml of solution.
	Each calibrator is comprised of the following concentrations ofanalytes,
PN	ISECalibrator	Na+mmol/L	K+mmol/L	Cl-mmol/L	CO2mmol/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 ISECalibrators	ATAC 8000 ISECalibrators
Device	New	Predicate
510(k) Number	K121027	K945271
PN	BT-6620943D ISE Low CalibratorBT-6620944D ISE High CalibratorBT-6620940D (Kit)	347240 ISE LowCalibrator347240 ISE HighCalibrator347-240 (Kit)
Product Type	Calibrators	same
Intended Use	For in-vitro diagnostics use to providecalibration points for the Na+, K+, Cl-and CO2 electrodes on the ATAC 8000instrument having an ISE Module	same
Matrix	Aqueous buffered solution of salts &preservatives in De-ionized water.Contains NO human or animalmaterials.	same
Packaging, Vial	Glass Vial	Same
Packaging, Product	Box Level, 2x20mL	2x6x20mL
Storage	18-25°C	same
Shelf Life for BT-6620943D	24 months	same
Shelf Life for BT-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 ofAnalyte Value	Instrument Used
Na, K	NIST 919a, 918a	IL 943 (Flame Photometry)
Cl	NIST 919a	Corning 925, SAT-500 SaltAnalyzer, (Titrimetric)
CO2	NIST 351	Hitachi 912, Olympus-BeckmanCX-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.

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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 (800) 638 2041 or (301) 796-7100 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

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.