(242 days)
Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode.
Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.
Diamond Diagnostics ISE Serum Standards and ISE Urine Standards are intended to serve as a direct replacement to Siemens (Bayer) Advia ISE Serum Standards and ISE Urine Standards.
Diamond Diagnostics ISE Serum Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products It is a liquid packaged in a 100mL high density polyethylene (HDPE) dropper bottle. It consists of one Serum Low Standard and one Serum High Standard sold as a set in a box.
Diamond ISE Urine Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products. It is a liquid packaged in a 100mL HDPE dropper bottle. It consists of one Urine Low Standard and one Urine High Standard sold as a set in a box.
This document describes the Diamond Diagnostics ISE Serum Standards and ISE Urine Standards, which are calibrators for medical devices. The document highlights the product's characteristics, intended use, and a comparison with a predicate device to demonstrate substantial equivalence.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the target values for each analyte in the standards, with a defined tolerance range. The "reported device performance" refers to the target values that the manufactured calibrators are designed to meet and are verified against.
Diamond Diagnostics ISE Serum Standard Low:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 130 ± 2 | 130 ± 2 |
| K+ | mmol/L | 3.5 ± 0.05 | 3.5 ± 0.05 |
| Cl- | mmol/L | 85 ± 2 | 85 ± 2 |
Diamond Diagnostics ISE Serum Standard High:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 160 ± 2 | 160 ± 2 |
| K+ | mmol/L | 6 ± 0.05 | 6 ± 0.05 |
| Cl- | mmol/L | 120 ± 2 | 120 ± 2 |
Diamond Diagnostics ISE Urine Standard Low:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 50 ± 2 | 50 ± 2 |
| K+ | mmol/L | 10 ± 0.2 | 10 ± 0.2 |
| Cl- | mmol/L | 50 ± 2 | 50 ± 2 |
Diamond Diagnostics ISE Urine Standard High:
| Analyte | Units | Acceptance Criteria (Target Value) | Reported Device Performance (as designed) |
|---|---|---|---|
| Na+ | mmol/L | 200 ± 3 | 200 ± 3 |
| K+ | mmol/L | 100 ± 2 | 100 ± 2 |
| Cl- | mmol/L | 180 ± 2 | 180 ± 2 |
The study demonstrates that the manufactured standards are tested to assure they meet these target values within the predetermined acceptance criteria.
2. Sample size used for the test set and the data provenance
- Test Set Description: The document refers to testing "reagents analytically prior to bottling" and "analytically during the bottling process and prior to release to stock for distribution." Additionally, "Six replicates of each sample are tested analytically for the electrolytes."
- Sample Size: Six replicates of each standard (ISE Serum Standard Low, ISE Serum Standard High, ISE Urine Standard Low, ISE Urine Standard High) were tested.
- Data Provenance: The data appears to be prospective, generated during the manufacturing and quality control process of the Diamond Diagnostics ISE Standards. The country of origin is not explicitly stated but implied to be the US given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device is a calibrator, and its performance is evaluated against chemical reference standards and methods, not expert human interpretation.
4. Adjudication method for the test set
This section is not applicable. The evaluation relies on objective analytical measurements rather than subjective human assessment requiring adjudication.
5. 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
This section is not applicable. The device is a chemical calibrator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a chemical calibrator. However, the performance of the calibrator itself is assessed in a "standalone" manner through analytical testing of its constituent analytes using specified reference methods.
7. The type of ground truth used
The ground truth for the test set is established by:
- Reference Standard Materials: NIST (National Institute of Standards and Technology) salts (NIST 919b for Na and Cl, NIST 918b for K) which are gravimetrically prepared.
- Reference Methods:
- IL 943 Flame Photometry for Na+ and K+.
- SAT-500 Salt Analyzer (Titrimetric method) for Cl-.
8. The sample size for the training set
This section is not applicable. The device is a calibrator, and its formulation and target values are based on established chemical principles and comparison to predicate devices, not a 'training set' in the machine learning sense. The "training" for such a device would be the formulation and manufacturing process designed to consistently achieve the specified concentrations.
9. How the ground truth for the training set was established
This section is not applicable. As explained in point 8, there isn't a "training set" in the traditional sense for this type of device. The "ground truth" for the calibrator's target values is established by:
- Gravimetric Preparation from NIST Standards: Analytes are derived from NIST certified reference materials.
- Analytical Verification using Reference Methods: The final concentrations are verified using established and accurate analytical methods (Flame Photometry and Titrimetry).
- Matching Predicate Device Values: The target values were chosen to match those of the predicate ADVIA ISE Serum Standards and ISE Urine Standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2014
DIAMOND DIAGNOSTICS, INC KATHY CRUZ QUALITY ASSURANCE MANAGER 333 FISKE ST HOLLISTON MA 01746
Re: K133751
Trade/Device Name: Diamond Diagnostics ISE Serum Standards. Diamond Diagnostics ISE Urine Standards Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: June 23, 2014 Received: June 24, 2014
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Courtney
Courtney H. Lias, Ph.D. 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) K133751
Device Name
Diamond Diagnostics ISE Serum Standards, Diamond Diagnostics ISE Urine Standards
Indications for Use (Describe)
Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode.
Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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) 429-0452www.diamonddiagnostics.com |
| Date Prepared: | 08/05/14 |
| Classification Name: | Calibrator, secondary |
| Trade Name: | Diamond Diagnostics ISE Serum StandardsDiamond Diagnostic ISE Urine Standards |
| Device Classification: | 21 CFR 862.1150 |
| Device Class: | Class II |
| Classification Panel: | Clinical Chemistry (75) |
| Product Code: | JIT |
| Indications for Use: | Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to providecalibration points for the sodium, potassium and chloride electrodes on ADVIA Chemistrysystems in Human Serum mode.Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to providecalibration points for the sodium, potassium and chloride electrodes on ADVIA Chemistrysystems in Human Urine mode. |
| Description of Device: | Diamond Diagnostics ISE Serum Standards and ISE Urine Standards are intended to serveas a direct replacement to Siemens (Bayer) Advia ISE Serum Standards and ISE UrineStandards.Diamond Diagnostics ISE Serum Standards consists of an aqueous buffered solution ofelectrolytes, and preservative in Deionized water. It contains NO human or animal productsIt is a liquid packaged in a 100mL high density polyethylene (HDPE) dropper bottle. Itconsists of one Serum Low Standard and one Serum High Standard sold as a set in a box. |
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The Serum Standards are comprised of the following concentrations of analytes.
| Na+mmol/L | K+mmol/L | Cl-mmol/L | |
|---|---|---|---|
| ISE SerumStandard Low | 130 ± 2 | 3.5 ± 0.05 | 85 ± 2 |
| ISE SerumStandard High | 160 ± 2 | 6.0 ± 0.05 | 120 ± 2 |
Diamond ISE Urine Standards consists of an aqueous buffered solution of electrolytes, and preservative in Deionized water. It contains NO human or animal products. It is a liquid packaged in a 100mL HDPE dropper bottle. It consists of one Urine Low Standard and one Urine High Standard sold as a set in a box.
The Urine Standards are comprised of the following concentrations of analytes.
| Na+mmol/L | K+mmol/L | Cl-mmol/L | |
|---|---|---|---|
| ISE UrineStandard Low | $50 \pm 2$ | $10 \pm 0.2$ | $50 \pm 2$ |
| ISE UrineStandard High | $200 \pm 3$ | $100 \pm 2$ | $180 \pm 2$ |
Predicate Device: Diamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Calibrators
Predicate 510(k) number(s): K121027
Comparison with predicate:
Diamond Diagnostics ISE Serum Standards
| Characteristics | Candidate DeviceDiamond Diagnostics ISE Serum Standards (Low and High) | Predicate DeviceDiamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Calibrators (K121027) |
|---|---|---|
| Product Type | Calibrator | same |
| Intended Use | For in-vitro diagnostics use in the calibration of sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Serum mode. | For in-vitro diagnostics use in the calibration of sodium, potassium, chloride and CO2 electrodes on ATAC 8000/Envoy 500 Chemistry systems. |
| Matrix | Aqueous buffered solution of salts & preservatives in Deionized water. Contains NO human or animal materials. | same |
| Levels | Low and High | same |
| Packaging | 100mL HDPE Dropper Bottle, sold as a set of 1 each High and Low Standard | 2 x 20mL Glass Vial |
| Storage | 18-25 °C | same |
| Shelf Life | 24 months | same |
| Open-Vial Stability | 30 Day | Use immediately after opening |
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Diamond Diagnostics ISE Urine Standards
| Similarities and Differences | ||
|---|---|---|
| Characteristics | Candidate Device Diamond Diagnostics ISEUrine Standards (Low and High) | Predicate DeviceDiamond Diagnostics ATAC8000/Envoy 500 ISE SerumCalibrators (K121027) |
| Product Type | Calibrator | same |
| Intended Use | For in-vitro diagnostics use in the calibration ofsodium, potassium, and chloride electrodes onADVIA Chemistry systems in Urine mode. | For in-vitro diagnostics use inthe calibration of sodium,potassium, chloride and CO2electrodes on ATAC 8000/Envoy 500 Chemistry systems. |
| Matrix | Aqueous buffered solution of salts & preservativesin Deionized water. Contains NO human or animalmaterials. | same |
| Levels | Low and High | same |
| Packaging | 100mL HDPE Dropper Bottle, sold as a set of 1each High and Low Standard | 2 x 20mL Glass Vial |
| Storage | 18-25℃ | same |
| Shelf Life | 24 months | same |
| Open-Vial Stability | 30 Day | Use immediately after opening |
Stability:
Accelerated (high temperature) stress test was conducted to support the stability claim of 24 months when stored at 18℃ to 25℃. Heat stressed reagents showed that the ISE Serum Standards and ISE Urine Standards parameters remained within specification. Open-Vial Stability was conducted to support the claim of 30 days at 18-25℃. Open-vial reagents showed that the ISE Serum Standards and ISE Urine Standards parameters remained within specification. Real time stability studies are in progress and will commence at 6 month intervals for 2 years at 18°C and 25°C. The solutions will be tested analytically for the electrolytes using reference methods. Flame Photometry will be used for the Na " and K . Silver/Silver Chloride Titration method is used for the Cl. Functional performance for calibration and control testing will likewise be performed.
Traceability:
All testing for analytes were conducted using Standards gravimetrically prepared from NIST salts. Testing was also conducted using reference methods.
| Analyte | Reference Standard Material Usedfor Determination of Analyte Value | Reference Method Used |
|---|---|---|
| Na, K | NIST 919b, 918b | IL 943 (Flame Photometry) |
| Cl | NIST 919b | SAT-500 Salt Analyzer, (Titrimetric) |
Value Assignment:
Target values were obtained by testing reagents analytically prior to bottling if necessary to meet specifications, and prior to release to stock for distribution. Each ISE Serum Standard High/Low and ISE Urine Standard High/Low is tested for Na *, K *, and CI , pH, conductivity, calibration and QC Control recovery
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- To assure reagents meet target values and are within the predetermined acceptance criteria reagents are . tested analytically, adjusted if necessary to meet specifications, prior to bottling. Each is tested analytically during the bottling process and prior to release to stock for distribution.
- . Six replicates of each sample are tested analytically for the electrolytes using reference methods. Flame Photometry is used for the Na * and K . Silver/Silver Chloride Titration method is used for the Cl . The IL 943 Flame Photometer is used for testing the Na " and the SAT-500 salt analyzer is used for testing the Cl.
- . Lot to lot variation is determined by analytically testing new lot vs. previous lot normalized to either an aqueous standard made with corresponding analyte NIST (National Institute of Standards and Technology) material or a known Calibrator.
Diamond ISE Serum Standard High/Low and ISE Urine Standard High/Low for ADVIA Chemistry Systems Target values:
| ISE Serum Standard Low | Units | TargetValue |
|---|---|---|
| Na+ | mmol/L | $130 \pm 2$ |
| K+ | mmol/L | $3.5 \pm 0.05$ |
| Cl- | mmol/L | $85 \pm 2$ |
| ISE Serum Standard High | Units | TargetValue |
|---|---|---|
| Na+ | mmol/L | 160 +/- 2 |
| K+ | mmol/L | 6 +/- 0.05 |
| Cl- | mmol/L | 120 +/- 2 |
| ISE Urine Standard Low | Units | TargetValue |
|---|---|---|
| Na+ | mmol/L | $50 +/- 2$ |
| K+ | mmol/L | $10 +/- 0.2$ |
| Cl- | mmol/L | $50 +/- 2$ |
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| ISE Urine Standard High | Units | TargetValue |
|---|---|---|
| Na+ | mmol/L | 200 +/- 3 |
| K+ | mmol/L | 100 +/- 2 |
| Cl- | mmol/L | 180 +/- 2 |
Specific Standards and Concentrations used
| Analyte | Standard | Concentration(mmol/L) |
|---|---|---|
| Na T | NIST 919b | 160, 140, 100, and 50 |
| Kt | NIST 918b | 100, 8, 5 and 0.5 |
| Cli | NIST 919b | 200, 125, 80, and 5 |
The target values were chosen to match the ADVIA ISE Serum Standards and ISE Urine Standards predicate.
Conclusion:
Based on the results submitted in this premarket notification Diamond Diagnostics ISE Serum Standards and ISE Urine Standards for Advia Chemistry systems are substantially equivalent to the Diamond Diagnostics ATAC 8000/Envoy 500 ISE Serum Standards in composition, and Intended use, for the calibration of Na+, K+, and Cl-Electrodes.
§ 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.