(35 days)
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
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.
The provided documentation describes the High Metabolite QUALICHECK, a quality control system. As such, the concept of "acceptance criteria" and "device performance" is focused on its ability to serve as a reliable control for other diagnostic devices, rather than directly diagnosing a condition. The "study" described is a value assignment study to establish the accepted control ranges for the device.
Here's a breakdown of the information requested:
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a quality control material are typically the established target ranges for its analytes, determined through a rigorous value assignment process. The "reported device performance" refers to the specific values found for the analytes within the control solution, which then form these target ranges.
| Analyte | Acceptance Criteria (Target Range) | Reported Device Performance (Established Range) |
|---|---|---|
| pO2 | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
| ctHb | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
| cGlucose | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
| cLactate | Mean ± 2SD (derived from the study) | Based on the mean and ±2SD of 144 measurements across 3 validated ABL7xx series instruments. Specific numerical values are not provided in the document. |
Note: The document states "Target ranges are calculated based on the mean ±2SD" but does not explicitly list the numerical target ranges or the actual performance values. This information would typically be found in the device's insert.
Study Details
This section focuses on the value assignment study for the High Metabolite QUALICHECK.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 72 ampoules (12 ampoules sampled from each of 6 trays). Additionally, a "reference batch" was used, though its size is not explicitly stated in terms of ampoules. A total of 144 measurements were performed for each parameter.
- Data Provenance: Not explicitly stated, but assumed to be generated in a controlled laboratory environment by the manufacturer (Radiometer Medical ApS, Denmark) as part of the product development and validation for regulatory submission. This is a prospective study for establishing control values.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable in the traditional sense for this type of device. The "ground truth" for a quality control material is established through precise and extensive instrumental measurements on a well-characterized batch.
- Qualifications of Experts: The measurements were performed on "a minimum of 3 validated ABL7xx series" instruments. The expertise lies in the calibration, validation, and operation of these high-precision instruments and the personnel trained to use them for quality control value assignment.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. The "ground truth" (target ranges) is established statistically from a large number of instrumental measurements (144 measurements per parameter) from established and validated analyzers, rather than through expert consensus or adjudication of subjective interpretations.
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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:
- MRMC Study: No. This device is a quality control material for in vitro diagnostic instruments, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical quality control solution, not an algorithm. Its "performance" is its ability to provide stable and accurate reference values when measured by compatible analyzers. The value assignment study itself is a standalone evaluation of the control solution's inherent characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth is established through reference method measurements or highly precise, validated instrumental measurements on a large, representative sample of the quality control material. Specifically, it's based on the statistical analysis (mean ± 2SD) of 144 measurements from validated ABL7xx series analyzers.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the initial production of the control material according to specifications.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. There is no training set for this type of device in the machine learning sense. The "ground truth" (i.e., the target values) for the product is established through the value assignment process described in point 6 above for the manufactured batches.
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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 212700 BroenshoejDenmark |
| 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
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:
·
| Similarities | |||
|---|---|---|---|
| Issue | SE Device | Predicate: QUALICHECK5+ (K980135) | |
| Form | Same | Liquid | |
| Base matrix | Same | Aqueous solution | |
| Blood GasMeasurement | Same | $pO_2$ | |
| OximetryMeasurement | Same | ctHb | |
| MetaboliteMeasurement | Same | cGlucose, cLactate | |
| Compatibleanalyzers | 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 MetaboliteQUALICHECK solution is anassayed quality control systemfor evaluating the accuracy andprecision of all parameterslisted on the insert specifyingthe control ranges.Analytes are: pO2, ctHb,cGlucose, cLactate | For In Vitro Diagnostic Use.This QUALICHECK5+ solutionis an assayed quality controlsystem for evaluating theaccuracy and precision of allparameters listed on the insertspecifying the control ranges.For professional use. | |
| Storage | 2 °C to 8 °C until expirationdate. | 2 °C to 25 °C until expirationdate, including up to a total of15 days at up to 32 °C | |
| Open Vial Claim | High Metabolite QUALICHECKsolutions are light and heatsensitive. Avoid storage indirect sunlight. Useimmediately after opening theampoule | Ampoules should beconditioned for at least fivehours at a constanttemperature between 18 °Cand 32 °C before use. Tomaintain the reliability of theblood gas parameters, youmust use the contents of theampoule immediately afteropening and according to theinstructions in the operator'smanual for the relevantanalyzer. | |
| 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 notincluded | cK+, cNa+, cCa2+, cCl | |
| Hemoglobin Measurement | Hemoglobin Measurement notincluded | ctBil | |
| Levels | One level | Four levels | |
| Target ranges | Target ranges, see Section12.02 Target values | Target ranges, see Section12.02 Target values | |
| Compatible analyzers | ABL800ABL817/827/837ABL77 | ABL5ABL500/510ABL505ABL80 - CO-OX SWABL80 - 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 |
11 - 11 - 11 -
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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).
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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
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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
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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)
§ 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.