(118 days)
Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU4xx and AU6xx instruments. For in-vitro diagnostics use.
Mission Olympus AU ISE Calibrators are intended to serve as a direct replacement to Olympus AU ISE Calibrators. They are aqueous solutions of salts & preservatives, containing NO human or animal materials, packaged in plastic bottles.
This is a 510(k) submission for in-vitro diagnostic calibrators, not an AI/ML device. Therefore, many of the typical acceptance criteria and study elements requested (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.
Here's an interpretation of the provided information in the context of the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability: Maintain performance over shelf life. | Accelerated (high temperature) stress testing supported stability. |
| Equivalence to Predicate Device: Perform comparably to the Olympus AU ISE Calibrators. | Side-by-side testing of Mission Olympus AU ISE Calibrators vs. Predicate (OEM) product on intended instruments demonstrated equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as this is a calibrator submission, not a study involving patient data. The "test set" here refers to the calibrator units and possibly instrument runs. The submission mentions testing across different instruments.
- Data Provenance: Not applicable in the sense of patient data. The provenance relates to the manufacturing and testing of the calibrator solutions and their evaluation on Olympus AU4xx and AU6xx instruments.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This concept is not applicable for this type of device (calibrators). Ground truth for calibrators is typically established through analytical methods and metrological traceability to reference materials, not through expert consensus on medical images or diagnostic outcomes.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication typically refers to resolving discrepancies among expert readers, which is not relevant for calibrator performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers in interpreting data (e.g., medical images). This submission is for physical calibrator solutions.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This is not an algorithm, but a physical diagnostic calibrator. Its performance is inherent to the chemical composition and manufacturing, and its functional performance is assessed on the intended instruments.
7. The Type of Ground Truth Used
- The "ground truth" for calibrators relates to their assigned values for Na+, K+, and Cl- parameters, which are established through precise analytical methods, typically traceable to higher-order reference measurement procedures or certified reference materials. The submission implies that the 'ground truth' for comparison was the performance of the predicate (OEM) Olympus AU ISE Calibrators.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device.
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Diamond Diagnostics 510(k) Submission for Olympus AU ISE Calibrators
4. 510(k) Summary
Owner's Name & Address:
Diamond Diagnostics Inc 333 Fiske Street Holliston MA 01746 FAX: 508-429-0452
Establishment Registration Number: 3003030793
Date of Preparation: Identification of the Device:
April 10, 2007
Contact Person:
Kathryn Thorsen
508-429-0450 x357
Quality Assurance Manager
Proprietary/Trade name: Mission Olympus AU ISE Calibrators Common name Calibrating Standard Classification name: Calibrator, Secondary (21 CFR 862.1150, Product Code JIT). The product code of JIT has been assigned to this device in the Classification Database.
Substantial Equivalence Table of Product Part Numbers & Trade Names
| Diamond/Mission Product | Olympus Equivalent |
|---|---|
| OY-AUH1012D ISE Mid Standard | AUH1012 ISE Mid Standard |
| OY-AUH1014D ISE Low Standard | AUH1014 ISE Low Standard |
| OY-AUH1015D ISE High Standard | AUH1015 ISE High Standard |
| OY-AUH1016D Low/High Urine Standard | AUH1016 Low/High Urine Standard |
Description of Device:
Mission Olympus AU ISE Calibrators are intended to serve as a direct replacement to Olympus AU ISE Calibrators.
Intended Use:
Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU4xx and AU6xx instruments.
| Characteristics | Mission Olympus AU ISE Calibrators | Olympus AU ISE Calibrators |
|---|---|---|
| PN | OY-AUH1012D, OY-AUH1014D, OY-AUH1015D,OY-AUH1016D | AUH1012, AUH1014, AUH1015, AUH1016 |
| Contents: | Aqueous solution of salts & preservativesContains NO human or animal materials. | Aqueous solution of salts & preservativesContains NO human or animal materials. |
| Container | Plastic bottles | Plastic bottles |
| Color | Clear solution | Clear solution |
| Package | OY-AUH1012D: 4 x 2L bottles in corrugated box,OY-AUH1014D & OY-AUH1015D: 4 X 100mLbottles with dropper tips & caps in corrugated box,OY-AUH1016D: 2 x 100mL Low Urine Standard(OY-AUH1016AD) & 2 x 100mL High UrineStandard (OY-AUH1016BD) all in plastics bottleswith dropper tips & caps in corrugated box | AUH1012: 4 x 2L bottles in corrugated box,AUH1014 & AUH1015: 4 X 100mL bottles withdropper tips & caps in corrugated box, AUH1016:2 x 100mL Low Urine Standard & 2 x 100mL HighUrine Standard all in plastics bottles with droppertips & caps in corrugated box |
| Intended Use | For in-vitro diagnostics use to provide calibrationpoints for Na+, K+ and Cl- electrodes on theOlympus AU4xx and AU6xx instruments. | For in-vitro diagnostics use to provide calibrationpoints for Na+, K+ and Cl- electrodes on theOlympus AU4xx and AU6xx instruments. |
| Storage / ShelfLife | 18-25°C 24-months | 18-25°C 24-months |
Technological Characteristics:
AUG - 8 2007
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Assessment of Non-Clinical Performance Data:
Tests were conducted to verify specific performance requirements:
- Accelerated (high temperature) stress test to support stability a.
Alian (ti- Side by side testing of Mission Olympus AU ISE Calibrators vs. Predicate (OEM) product on intended b. instruments to demonstrate equivalence
Assessment of Clinical Performance Data: NA
Conclusions:
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circle around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diamond Diagnostics Inc. c/o Ms. Kathryn Thorsen Quality Assurance Manager 333 Fiske Street Holliston, MA 01746
AUG - 8 2007
Re: K071039 Trade/Device Name: Mission Olympus AU ISE Calibrators Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: June 22, 2007 Received: June 25, 2007
Dear Ms. Thorsen:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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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4. Indications for Use Statement
510(k) Number (if known): K071039
Device Name: Mission Olympus AU ISE Calibrators
Indications For Use:
Mission Olympus AU ISE Calibrators are intended to provide calibration points for Na+, K+ and Cl- electrodes on the Olympus AU400 and AU600 instruments.
For In Vitro Diagnostic Use
Prescription Use × (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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
§10(k) K071039
§ 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.