This Hematocrit and 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: cGlucose, cLactate, Hct

Device Description

Hematocrit and Metabolite QUALICHECK is a two-level quality control system consisting of:

Hematocrit and Metabolite QUALICHECK, Level 1 (S7170), 944-039
Hematocrit and Metabolite QUALICHECK, Level 2 (S7180), 944-040

The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.

The quality control solution is an aqueous solution containing an organic buffer, acid, salts, metabolites, and a preservative.

AI/ML Overview

The provided text describes the Hematocrit and Metabolite QUALICHECK, a quality control system, and its substantial equivalence to a predicate device. However, the document does not contain the specific acceptance criteria, study details proving meeting these criteria, or most of the requested information about test and training sets, expert involvement, or comparative effectiveness studies.

This device is a quality control material, not a diagnostic or prognostic medical device that would typically involve AI, human-in-the-loop performance, or extensive clinical trials with patient data and expert ground truth establishment in the manner usually associated with the questions asked. The performance is assessed by comparing its measured values to established reference values and demonstrating stability.

Therefore, many of your requested points cannot be answered from the provided text. I will answer what is available and indicate when information is not present.

Acceptance Criteria and Device Performance (Limited Information Available)

The document states: "All study results met the acceptance criteria," but it does not explicitly list the acceptance criteria in a table or otherwise. It also does not report device performance data in a quantitative manner against specific criteria. The closest information available is in the "Stability" section, which mentions:

Stability Claim: Control solutions are stable for 2 years at 2 °C to 25 °C.
Performance against "Acceptance Criteria" (unspecified): "All study results met the acceptance criteria."

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Specific criteria not provided in document	Specific performance data against criteria not provided.
Stability for 2 years at 2 °C to 25 °C	Met the (unspecified) acceptance criteria for stability.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Hct: For value assignment, 30 ampoules were sampled from the batch (5 from each of 6 trays) and 30 ampoules were sampled from a reference batch. Measurements were repeated 5 times per ABL555 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
- Glucose and Lactate: Similar sampling: 30 ampoules from the batch and 30 from a reference batch. Measurements were repeated 5 times per EML105 analyzer (60 total measurements for each set of ampoules across 2+ analyzers).
Data Provenance: Not explicitly stated, but the company (Radiometer Medical ApS) is based in Denmark. The study is part of the regulatory submission process for a medical device quality control, suggesting it is a controlled, prospective study for regulatory purposes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable or not specified. Ground truth for quality control materials for analytes like glucose, lactate, and hematocrit is established through highly calibrated reference methods and analyzers, not typically by human expert consensus or interpretation in the same way as imaging or diagnostic assessments.
Qualifications of Experts: Not applicable/not specified. The "ground truth" (referred to as "true value" in the document) is determined by "validated ABL555" and "validated EML105" analyzers and "validated algorithms" in an Excel spreadsheet.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. The ground truth is established by instrumental measurements and calculations, not human 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

MRMC Study: No. This device is a quality control material for analytical instruments, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Yes, in a sense. The "performance" of this device is its inherent accuracy and stability as a quality control material, which is assessed instrumentally without human in-the-loop performance altering its "reading." The device itself doesn't have an "algorithm" in the AI sense; its function is to provide known analyte concentrations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: "True value" established through measurements on validated reference analyzers (ABL555 for Hct, EML105 for Glucose and Lactate) and validated algorithms for calculation. This is an analytical ground truth based on reference methods.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a quality control material, not an AI algorithm that requires a "training set." The materials are manufactured, and then their "true values" and stability are verified.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no "training set." The "true values" for the device itself (which are the reference for other instruments using it for quality control) are established as described in point 7.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2015

RADIOMETER MEDICAL ApS METTE HARPSOEE REGULATORY AFFAIRS SPECIALIST AKANDEVEJ 21 2700 BRONSHOJ, DENMARK

Re: K150226

Trade/Device Name: Hematocrit and Metabolite OUALICHECK Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJS Dated: March 27, 2015 Received: March 30, 2015

Dear Mette Harpsoee:

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 (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.

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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/Resourcesfor You/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 H. Lias -S

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) K150226

Device Name Hematocrit and Metabolite QUALICHECK

Indications for Use (Describe)

This Hematocrit and 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: cGlucose, cLactate, Hct

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CFR 801 Subpart D)	❍ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. Submitter and contact information

Submitter
Company Name:	Radiometer Medical ApS
ER Number:	3002807968
Address:	Aakandevej 212700 BroenshoejDenmark
Phone:	+45 3827 3827
Fax:	+45 3827 2727

Contact Person

Name:	Mette Skytte Harpsoee
Function:	Regulatory Affairs Specialist
E-mail:	mette.skytte@radiometer.dk
Phone:	+45 3827 3114
Fax:	+45 3827 2727

Date prepared

May 7, 2015 Date:

2. a. Device Information

Device Name:	Hematocrit and Metabolite QUALICHECK
Common Name:	Quality Control

Classification :

Classification name	CFR Section	Device Class	Product Code
Controls for blood-gases,(assayed and unassayed)	862.1660	I, reserved	JJS

2. b. Device Description

Hematocrit and Metabolite QUALICHECK is a two-level quality control system consisting of:

Hematocrit and Metabolite QUALICHECK, Level 1 (S7170), 944-039 ●
. Hematocrit and Metabolite QUALICHECK, Level 2 (S7180), 944-040

The system consists of 30 ampoules per box. One ampoule contains 2 mL of solution.

The quality control solution is an aqueous solution containing an organic buffer, acid, salts, metabolites, and a preservative.

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3 Intended Use

This Hematocrit and 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: cGlucose, cLactate, Hct

4. Predicate device: QUALICHECK5+ (K980135)

Substantial Equivalence

The Hematocrit and 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

Similarities
Issue	SE Device	Predicate: QUALICHECK5+(K980135)
Form	Same	Liquid
Base matrix	Same	Aqueous solution
Preservatives	Same	ProClin 950
Parameters	$c$ Glucose, $c$ Lactate,Hct	pH, pCO2, pO2, $c$ Na+, $c$ K+, $c$ Ca2+,$c$ Cl-, $c$ Glucose, $c$ Lactate, $c$ tHb, sO2,FO2Hb, FCOHb, FMetHb, FHbF,$c$ tBil
Intended Use	This Hematocrit and MetaboliteQUALICHECK solution is anassayed quality control system forevaluating the accuracy andprecision of all parameters listedon the insert specifying the controlranges.	For In Vitro Diagnostic Use. ThisQUALICHECK5+ solution is anassayed quality control system forevaluating the accuracy andprecision of all parameters listedon the insert specifying the controlranges. For professional use.
Storage	2 °C to 25 °C until expiration date.	2 °C to 25 °C until expiration date,including up to a total of 15 daysat up to 32 °C.

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Differences
Issue	SE Device	Predicate: QUALICHECK5+ (K980135)
Levels	Two levels	Four levels
Target ranges	Target ranges, see Section12.02 Target values	Target ranges, see Section 12.02 Target values
Compatibleanalyzers	• ABL77• ABL555• ABL605/615/625• ABL80 FLEX• ABL80 BASIC• EML105	• ABL5• ABL500/505/510/520/555• ABL600/605/610/615/620/625• ABL700/705/710/715/720/725/730/735• ABL805/810/815/820/825/830/835/800BASIC• ABL80 - CO-OX• ABL80 - OSM• ABL90 FLEX• EML100/105

5. Stability

Stability claims are based on real time stability studies. Control solutions are stable for 2 years at 2 °C to 25 °C. Multiple test points were tested, with six measurements at each test point. All study results met the acceptance criteria.

In-use Stability: The contents should be used immediately after opening.

6. Value Assignment

To determine the true value for each parameter and thereby the assigned values and control ranges for Hematocrit and Metabolite QUALICHECK, the following sampling and measurements are performed:

Hct:

6 trays are sampled randomly from the Hematocrit and Metabolite QUALICHECK batch. . Each tray contains 1000 ampoules.
5 ampoules are sampled from each of the 6 trays ●
30 ampoules are sampled from the reference batch ●
. Measurements are performed on at least 2 validated ABL555
Measurements of Hct are performed alternately on the reference ampoule and the sample ampoule. This is repeated 5 times on each ABL555 – 60 measurements in total
. Measurement results are recorded and analyzed in a validated Excel spreadsheet

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Glucose and lactate:

6 trays are sampled randomly from the Hematocrit and Metabolite QUALICHECK batch. . Each trav contains 1000 ampoules.
. 5 ampoules are sampled from each of the 6 trays
30 ampoules are sampled from the reference batch .
Measurements are performed on at least 2 validated EML105 ●
Measurements of glucose and lactate are performed alternately on the reference ● ampoule and the sample ampoule. This is repeated 5 times on each EML105 - 60 measurements in total
Measurement results are recorded and analyzed in a validated Excel spreadsheet ●

Calculation of true value is described in the test instruction for each level. Assigned values are calculated from the true values by validated algorithms. Control ranges are based on the assigned values ± validated 95% confidence intervals.

7. Conclusion

The Hematocrit and Metabolite QUALICHECK is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate device: QUALICHECK5+ (K980135).

Regulation Number and Section

§ 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.