(239 days)
Not Found
No
The device description and performance studies focus on chemical calibrators for ion-selective electrodes, with no mention of AI or ML technologies.
No
The document explicitly states the device is for "in-vitro diagnostics use" and provides calibration points for analytical instruments, which are not therapeutic actions.
No
The device is a calibrator, used to provide calibration points for electrodes on diagnostic instruments. While it is intended for "in-vitro diagnostics use," it is a tool for calibration, not a diagnostic device itself that directly diagnoses a disease or condition in a patient.
No
The device description clearly states the device is a buffered solution packaged in physical containers (foil bag, plastic bottle), indicating it is a chemical reagent, 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 in instruments that measure analytes (Na+, K+, and Cl-) in biological samples (implied by the use of ISE modules on clinical chemistry analyzers). This is a core function of an in vitro diagnostic device.
- Device Description: While the description details the composition and packaging, it supports the intended use as a reagent used in a diagnostic process.
The document clearly identifies the device's purpose as being used in vitro (outside the body) to aid in a diagnostic process by calibrating the instruments that perform the tests.
N/A
Intended Use / Indications for 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.
Product codes
JIT
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
333 Fiske Street
Holliston MA 01746 | |
|------------------------|--------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Kathy Cruz
Quality Assurance Manager
Phone: (508) 429-0450 ext. 358
Fax: (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 | |
1
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+
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
Predicate 510(k) number(s):
Comparison with predicate:
| Characteristics | Diamond Calibrators for Medica ISE
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
calibration points for the $Na^+$ , $K^+$ , and $Cl^-$
electrodes on the Polymedco Poly-Chem,
and Randox Daytona instruments having
the Medica ISE Module | For in-vitro diagnostics use to provide
calibration points for the $Na^+$ , $K^+$ , and
$Cl^-$ electrodes on the Polymedco Poly-
Chem, Randox Daytona, and Medica
Easy Electrolytes instruments having
the Medica ISE Module |
| Matrix | Buffered solution of salts & preservatives
Contains NO human or animal materials. | Buffered solution of salts &
preservatives
Contains NO human or animal
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.
2
Substantial Equivalence Discussion
Diamond Diagnostics claims substantial equivalence to the predicate calibrators listed below:
| Diamond Diagnostics Product | Medica ISE Module Calibrators |
|---|---|
| ME-6370D | |
| Diamond Medica ISE Module Calibrant A | 006370-001 |
| Medica ISE Module Calibrant A | |
| ME-5410D | |
| Diamond Medica ISE Module Calibrant B | 5410 |
| 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 | |
| calibration points for the Na+, K+, and Cl- | ||
| electrodes on the Polymedco Poly-Chem, | ||
| and Randox Daytona instruments having | ||
| the Medica ISE Module | For in-vitro diagnostics use to provide | |
| calibration points for the Na+, K+, and | ||
| Cl- electrodes on the Polymedco | ||
| Poly-Chem, Randox Daytona, and | ||
| Medica Easy Electrolytes instruments | ||
| having the Medica ISE Module | ||
| Matrix | Buffered solution of salts & preservatives | |
| Contains NO human or animal materials. | Buffered solution of salts & | |
| preservatives | ||
| Contains NO human or animal | ||
| 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 |
3
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,
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