Hematocrit and Metabolite QUALICHECK

K150226 · Radiometer Medical Aps · JJS · May 13, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150226
• Device Name: Hematocrit and Metabolite QUALICHECK
• Applicant: Radiometer Medical Aps
• Product Code: JJS · Clinical Chemistry
• Decision Date: May 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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

Device Story

Hematocrit and Metabolite QUALICHECK is a two-level aqueous quality control system used in clinical settings to verify the accuracy and precision of blood gas and metabolite analyzers. The system consists of ampoules containing an aqueous solution of metabolites, salts, acid, and organic buffer with ProClin 950 preservative. Healthcare professionals use the solution to perform quality control checks on compatible Radiometer ABL and EML series analyzers. By measuring the control solution and comparing results against assigned target ranges, clinicians ensure the analyzer is functioning correctly, which supports reliable diagnostic decision-making for patient blood testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed a 2-year shelf life at 2 °C to 25 °C. Value assignment was performed using validated ABL555 and EML105 analyzers, with 60 measurements per analyte to establish true values and 95% confidence intervals.

Technological Characteristics

Aqueous solution containing organic buffer, acid, salts, metabolites, and ProClin 950 preservative. Two-level system provided in 2 mL ampoules. Storage 2 °C to 25 °C. Compatible with specific Radiometer ABL and EML analyzer models. Value assignment uses validated algorithms and statistical analysis of measurement data.

Indications for Use

Indicated for use as an assayed quality control system for evaluating the accuracy and precision of cGlucose, cLactate, and Hct parameters on compatible analyzers. For professional use.

Regulatory Classification

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.

Predicate Devices

• QUALICHECK5+ (K980135)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:20px">✓</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:20px">❍</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# 1. Submitter and contact information

| <b>Submitter</b> | |
|------------------|---------------------------------------------|
| Company Name: | Radiometer Medical ApS |
| ER Number: | 3002807968 |
| Address: | Aakandevej 21<br>2700 Broenshoej<br>Denmark |
| Phone: | [phone] |
| Fax: | [phone] |

#### Contact Person

| Name: | Mette Skytte Harpsoee |
|-----------|-------------------------------|
| Function: | Regulatory Affairs Specialist |
| E-mail: | [e-mail] |
| Phone: | [phone] |
| Fax: | [phone] |

#### 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,<br>(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+<br>(K980135) |
| Form | Same | Liquid |
| Base matrix | Same | Aqueous solution |
| Preservatives | Same | ProClin 950 |
| Parameters | $c$ Glucose, $c$ Lactate,<br>Hct | pH, pCO2, pO2, $c$ Na+, $c$ K+, $c$ Ca2+,<br>$c$ Cl-, $c$ Glucose, $c$ Lactate, $c$ tHb, sO2,<br>FO2Hb, FCOHb, FMetHb, FHbF,<br>$c$ tBil |
| Intended Use | This Hematocrit and Metabolite<br>QUALICHECK solution is an<br>assayed quality control system for<br>evaluating the accuracy and<br>precision of all parameters listed<br>on the insert specifying the control<br>ranges. | For In Vitro Diagnostic Use. This<br>QUALICHECK5+ solution is an<br>assayed quality control system for<br>evaluating the accuracy and<br>precision of all parameters listed<br>on the insert specifying the control<br>ranges. For professional use. |
| Storage | 2 °C to 25 °C until expiration date. | 2 °C to 25 °C until expiration date,<br>including up to a total of 15 days<br>at 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 Section<br>12.02 Target values | Target ranges, see Section 12.02 Target values |
| Compatible<br>analyzers | • ABL77<br>• ABL555<br>• ABL605/615/625<br>• ABL80 FLEX<br>• ABL80 BASIC<br>• EML105 | • ABL5<br>• ABL500/505/510/520/555<br>• ABL600/605/610/615/620/625<br>• ABL700/705/710/715/720/725/730/735<br>• ABL805/810/815/820/825/830/835/800BASIC<br>• ABL80 - CO-OX<br>• ABL80 - OSM<br>• ABL90 FLEX<br>• 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).