(35 days)
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No
The document describes a quality control solution for evaluating the accuracy and precision of laboratory parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the chemical composition and stability of the control solution.
No
The device is described as a quality control system for evaluating the accuracy and precision of analytical parameters, not for treating a disease or condition. While it contains biological components, its purpose is for diagnostic quality control, not therapeutic intervention.
No
This device is a quality control system used to evaluate the accuracy and precision of analytical parameters, not a device that diagnoses medical conditions.
No
The device description explicitly states it is a "single level quality control system consisting of: High Metabolite QUALICHECK (S7570). The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution. The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative." This describes a physical, liquid-based quality control material, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges." This is a classic function of an IVD, which is used to test samples taken from the human body (in this case, to ensure the accuracy of the instruments testing those samples).
- Device Description: The description details a solution containing biological buffer, salts, metabolites, and a preservative. These are components typically found in IVD reagents or controls.
- Analytes: The listed analytes (pO2, ctHb, cGlucose, cLactate) are all parameters measured in biological samples for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K980135 QUALICHECK5+) which is also a quality control system for similar parameters further supports its classification as an IVD.
Quality control materials used to verify the performance of diagnostic tests are considered IVDs themselves.
N/A
Output:
Intended Use / Indications for Use
This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.
Analytes are: pO2, ctHb, cGlucose, cLactate
Product codes
JJS
Device Description
High Metabolite QUALICHECK is a single level quality control system consisting of:
- High Metabolite QUALICHECK (S7570) .
The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.
The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
To determine the assigned values and control ranges for the High Metabolite QUALICHECK, six (6) trays of 1000 ampoules are sampled randomly from the Range+ QUALICHECK batch. Twelve ampoules are sampled from each of the trays and 72 ampoules are sampled from the reference batch. The samples are conditioned and shaken at 25°C in a water bath for 6 hours. Measurements are performed on a minimum of 3 validated ABL7xx series with data collection. Measurement of each parameter is performed alternately on the reference ampoule and the sample and repeated 12 times on each ABL7xx for a total of 144 measurements. Target ranges are calculated based on the mean ±2SD.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Traditional 510(k): High Metabolite OUALICHECK
RADIOMETER
Section 5. 510(k) Summary
1 Administrative
Device Information High Metabolite QUALICHECK Device Name: Common Name: Quality Control Product Code: ાદ Registration Number: 21 CFR 862.1660 Classification: Class I Classification Panel: Clinical Chemistry
| Submitter | |
|---|---|
| Company Name: | Radiometer Medical ApS |
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denmark | |
| Phone: | +45 3827 3827 |
| Fax: | +45 3827 2727 |
2 Description of Device
High Metabolite QUALICHECK is a single level quality control system consisting of:
- High Metabolite QUALICHECK (S7570) .
The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.
The quality control solution is an aqueous solution containing a biological buffer, salts, metabolites, and a preservative.
3 Intended Use
This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.
Analytes are: pO2, ctHb, cGlucose, cLactate
4 Substantial Equivalence
The High Metabolite QUALICHECK is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:
510(k) Number/Device Manufacturer: K980135 QUALICHECK5+, Radiometer Medical ApS
MAR 26 2013
1
:
·
| Similarities | |||
|---|---|---|---|
| Issue | SE Device | Predicate: QUALICHECK5+ (K980135) | |
| Form | Same | Liquid | |
| Base matrix | Same | Aqueous solution | |
| Blood Gas | |||
| Measurement | Same | $pO_2$ | |
| Oximetry | |||
| Measurement | Same | ctHb | |
| Metabolite | |||
| Measurement | Same | cGlucose, cLactate | |
| Compatible | |||
| analyzers | Same | ABL520 ABL555 ABL600/605/610/615/620/625 ABL700/705/710/715/720/725/730/735 ABL805/810/815/820/825/830/835/ BASIC EML 105 | |
| Differences | |||
| Issue | SE Device | Predicate: QUALICHECK5+ | |
| (K980135) | |||
| Intended Use | This High Metabolite | ||
| QUALICHECK solution is an | |||
| assayed quality control system | |||
| for evaluating the accuracy and | |||
| precision of all parameters | |||
| listed on the insert specifying | |||
| the control ranges. | |||
| Analytes are: pO2, ctHb, | |||
| cGlucose, cLactate | For In Vitro Diagnostic Use. | ||
| This QUALICHECK5+ solution | |||
| is an assayed quality control | |||
| system for evaluating the | |||
| accuracy and precision of all | |||
| parameters listed on the insert | |||
| specifying the control ranges. | |||
| For professional use. | |||
| Storage | 2 °C to 8 °C until expiration | ||
| date. | 2 °C to 25 °C until expiration | ||
| date, including up to a total of | |||
| 15 days at up to 32 °C | |||
| Open Vial Claim | High Metabolite QUALICHECK | ||
| solutions are light and heat | |||
| sensitive. Avoid storage in | |||
| direct sunlight. Use | |||
| immediately after opening the | |||
| ampoule | Ampoules should be | ||
| conditioned for at least five | |||
| hours at a constant | |||
| temperature between 18 °C | |||
| and 32 °C before use. To | |||
| maintain the reliability of the | |||
| blood gas parameters, you | |||
| must use the contents of the | |||
| ampoule immediately after | |||
| opening and according to the | |||
| instructions in the operator's | |||
| manual for the relevant | |||
| analyzer. | |||
| Preservatives | Germall II, Kathon | ProClin 950 | |
| Blood Gas Measurement | pH, pCO2 not included | pH, pO2, pCO2 in all four levels | |
| Oximetry Measurement | sO2 FO2Hb, FCOHb, FMetHb, | ||
| FHbf not included | sO2 FO2Hb, FCOHb, FMetHb, | ||
| FHbf in all four levels | |||
| Electrolyte Measurement | Electrolyte Measurement not | ||
| included | cK+, cNa+, cCa2+, cCl | ||
| Hemoglobin Measurement | Hemoglobin Measurement not | ||
| included | ctBil | ||
| Levels | One level | Four levels | |
| Target ranges | Target ranges, see Section | ||
| 12.02 Target values | Target ranges, see Section | ||
| 12.02 Target values | |||
| Compatible analyzers | ABL800 | ||
| ABL817/827/837 | |||
| ABL77 | ABL5 | ||
| ABL500/510 | |||
| ABL505 | |||
| ABL80 - CO-OX SW | |||
| ABL80 - OSM SW | |||
| 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | Differences | ||
| Ssue | SE Device | Predicate: QUALICHECK5+ | |
| (K980135) | |||
| ABL90 Flex |
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5. Stability
Stability studies and claims are based on real time stability study. Control solutions are stable for 2 years at 2-8 degrees C.
In-use Stability: The contents should be used immediately after opening.
6. Value Assignment
To determine the assigned values and control ranges for the High Metabolite QUALICHECK, six (6) trays of 1000 ampoules are sampled randomly from the Range+ QUALICHECK batch. Twelve ampoules are sampled from each of the trays and 72 ampoules are sampled from the reference batch. The samples are conditioned and shaken at 25°C in a water bath for 6 hours. Measurements are performed on a minimum of 3 validated ABL7xx series with data collection. Measurement of each parameter is performed alternately on the reference ampoule and the sample and repeated 12 times on each ABL7xx for a total of 144 measurements. Target ranges are calculated based on the mean ±2SD.
7. Conclusion
The High Metabolite QUALICHECK is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate device: QUALICHECK5+ (K980135).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is black, and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2013
Radiometer Medical Aps c/o Martin Gabler Aakandevej 21, Broenshoej DENMARK DK-2700
Re: K130415
Trade/Device Name: High Metabolite QUALICHECK Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJS Dated: February 06, 2013 Received: February 19, 2013
Dear Mr. Gabler:
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.
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.html for
5
Page 2-Mr. Gabler
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 -S for
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
6
Indications for Use
510(k) Number (if known): K130415
Device Name: High Metabolite QUALICHECK
Indications for Use:
This High Metabolite QUALICHECK solution is an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.
Analytes are: pO2, ctHb, cGlucose, cLactate
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)
YungW.D.Chan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)