For In Vitro Diagnostic Use. This Range+ 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.

Device Description

Range+ QUALICHECK is a three level quality control system consisting of:

Range+ QUALICHECK, LEVEL 1 (S7930) .
Range+ QUALICHECK, LEVEL 2 (S7940) .
Range+ QUALICHECK, LEVEL 3 (S7950) .

Each level 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, glucose, lactate, dyes and a preservative, and it is equilibrated with carbon dioxide and oxygen.

AI/ML Overview

The provided text describes a 510(k) submission for a quality control system, Range+ QUALICHECK, used to evaluate the accuracy and precision of various analytes in blood gas, oximetry, electrolyte, and metabolite measurements. The study presented here is focused on establishing the value assignments and control ranges for the device, rather than proving its acceptance against specific performance criteria in the way one might for a diagnostic test with sensitivity/specificity targets.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a quality control system, so the "performance" here relates to the establishment of its control ranges. The acceptance criteria for the value assignment process are implicitly defined by the methodology used to calculate the target ranges.

Acceptance Criteria/Methodology	Reported Device Performance (Value Assignment)
Ground Truth Establishment:	Twelve ampoules sampled from each of six trays (total 72 ampoules) from the Range+ QUALICHECK batch and 72 ampoules from a reference batch.
Samples Conditioned	Conditioned and shaken at 25°C in a water bath for 6 hours.
Measurement Devices	Measurements performed on a minimum of 3 validated ABL7xx series devices.
Measurement Repetition	Measurement of each parameter performed alternately on reference and sample ampoule, repeated 12 times on each ABL7xx.
Control Range Calculation:	Target ranges calculated based on the mean ±2SD of the collected measurements for each analyte.
Stability Study:	Real-time stability studies conducted.
Shelf Life Claim	Stable for 2 years at 2-8°C.
In-use Stability Claim	Ampoules conditioned for at least 5 hours at 18-32℃ before use; contents used immediately after opening.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: For value assignment, 72 ampoules from the Range+ QUALICHECK batch and 72 ampoules from a reference batch were used. Each parameter was measured 12 times on a minimum of 3 devices, leading to at least 144 measurements per parameter. (Calculated as 12 repetitions x 3 devices x 4 ampoules, assuming at least 4 ampoules are measured on each device in an alternating fashion, though the text states "12 times on each ABL7xx for a total of 144 measurements" which suggests 12 measurements per ampoule * 3 devices * 4 ampoules? Or 12 measurements per device for a specific ampoule for a total of 144, if there are 12 different ampoules per device). The more direct reading is 12 repetitions * 3 devices = 36 measurements per ampoule * 4 ampoules measured per device, so 12 * 3 * 4 = 144. However, the text says 12 times on each ABL7xx for a total of 144 measurements so this means that 12 sample ampoules are measure 12 times on each ABL7xx? The interpretation of 12 times on each ABL7xx for a total of 144 measurements as meaning 12 individual tests per ABL7xx * 3 ABL7xx devices * some number of distinct ampoules leading to 144 total measurements is uncertain. A more direct reading could be 12 individual measurements per ampoule * 12 ampoules = 144, if using only one ABL7xx device? The text could be clearer here.
Data Provenance: The document does not explicitly state the country of origin of the data. Given the submitter's address (Aakandevej 21, 2700 Broenshoej, Denmark), it is strongly implied that the studies were conducted in Denmark or by the submitting company. The study is prospective as it involves controlled measurements to establish values for the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for this device is the assigned value and control range for each analyte. This is established through a rigorous measurement process rather than expert consensus on subjective interpretations (like radiology images).

Number of Experts: Not applicable in the traditional sense of medical expert reviewers. The "ground truth" (assigned values) is determined by the analytical performance of validated ABL7xx series devices and a statistical calculation (mean ±2SD).
Qualifications of Experts: Not applicable. The "expertise" lies in the validation of the ABL7xx devices and the adherence to the described measurement protocol.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of subjective assessments. The results are quantitative measurements. The "adjudication" is inherent in the statistical calculation of the mean and standard deviation from repeated measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for diagnostic devices where human readers interpret medical cases. This device is an in-vitro diagnostic quality control material, and its performance is evaluated through analytical measurements and statistical determination of control ranges, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense relevant to a QC material. The performance described (value assignment and stability) represents the standalone performance of the Range+ QUALICHECK material when analyzed on compatible devices (ABL7xx series). There is no "human-in-the-loop" component for the performance of the QC material itself; it's about the inherent properties and measured values of the solution.

7. The Type of Ground Truth Used

The ground truth used is the assigned values and control ranges derived from repeated analytical measurements on validated laboratory instruments (ABL7xx series devices) using a specified protocol. This is essentially an instrument-derived quantitative ground truth.

8. The Sample Size for the Training Set

The provided text describes the process for value assignment which serves as the "ground truth" or reference for the quality control material. It doesn't explicitly refer to a "training set" in the context of an algorithm or AI model development. The data used for determining the assigned values and control ranges is:

72 ampoules from the Range+ QUALICHECK batch.
72 ampoules from a reference batch.
For each parameter, a minimum of 144 measurements (12 repetitions on each of at least 3 validated ABL7xx series devices).

9. How the Ground Truth for the Training Set Was Established

As explained in points 3 and 7, the "ground truth" (assigned values and control ranges) is established through a precise and controlled measurement protocol:

Multiple ampoules (72 from the new batch, 72 from a reference batch) are prepared by conditioning at 25°C for 6 hours.
Measurements are performed on a minimum of 3 validated ABL7xx series devices.
For each parameter, 12 alternating measurements (between sample and reference ampoules) are taken on each ABL7xx device, totaling at least 144 measurements per parameter.
The target ranges are then calculated as the mean ±2 standard deviations of these collected measurements.

Summary

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510(k) Summary

1 Administrative

K130236

MAR 1 5 2013

Device Information Device

Device Name:	Range+ QUALICHECK, LEVEL 1
	Range+ QUALICHECK, LEVEL 2
	Range+ QUALICHECK, LEVEL 3
Common Name:	Quality Control
Product Code:	JJS
Registration Number:	21 CFR 862.1660
Classification:	Class I, Reserved
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

Range+ QUALICHECK is a three level quality control system consisting of:

Range+ QUALICHECK, LEVEL 1 (S7930) .
Range+ QUALICHECK, LEVEL 2 (S7940) .
Range+ QUALICHECK, LEVEL 3 (S7950) .

Each level 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, glucose, lactate, dyes and a preservative, and it is equilibrated with carbon dioxide and oxygen.

3 Intended Use

Analytes are:

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pH, pCO2, pO2, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHbF , cK+, cNa+, cCa2+, gCl+, cGlu, cLac, ctBil

4 Substantial Equivalence

The Range+ QUALICHECK Level 1-3 is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:

510(k) Number/Device Manufacture:

. ←

・・

:--

K980135 QUALICHECK5+, Radiometer Medical ApS

Issue	SE Device	Predicate: QUALICHECK5+ (K980135)
Form	Same	Liquid
Base matrix	Same	Aqueous solution
Preservatives	Same	ProClin 950
Open Vial Claim	Same	Ampoules should be conditioned for at least five hoursat a constant temperature between 18 °C and 32 °before use. To maintain the reliability of the blood gasparameters, you must use the contents of the ampouleimmediately after opening and according to theinstructions in the operator's manual for the relevantanalyser.
Blood GasMeasurement	Same	pH, pO₂, pCO₂
OximetryMeasurement	Same	ctHb, sO₂ FO₂Hb, FCOHb, FMetHb
ElectrolyteMeasurement	Same	cK⁺, cNa⁺, cCa²⁺, cCl⁻
MetaboliteMeasurement	Same	cGlucose, cLactate
HemoglobinMeasurement	Same	ctBil
Compatibleanalyzers	Same	ABL700/705/710/715/720/725/730/735 ABL805/810/815/820/825/830/835 ABL80 - OSM SW ABL90 FLEX

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Differences
Issue	SE Device	Predicate: QUALICHECK5+(K980135)
Intended Use	For In Vitro Diagnostic Use.This Range+ 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:pH, pCO2, pO2, ctHb, sO2,FO₂Hb, FCOHb, FMetHb, FHbF ,cK+, cNa+, cCa2+, cCl-, cGlu,	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 date5 hours between 18 – 32°C	2 °C to 25 °C until expiration date, including up to a total of 15 days at up to 32 °C
Oximetry Measurement	FHbf in Level 1	FHbf in all four levels
Levels	Three levels	Four levels
Target ranges	Target ranges, see Section12.02 Target values	Target ranges, see Section12.02 Target values

5 Stability

Stability studies and claims are based on real-time study. Control solutions are stable for 2 years at 2-8°C.

In-use Stability: Ampoules should be conditioned for at least 5 hours at a constant temperature between 18-32℃ before use. The contents should be used immediately after opening.

6 Value Assignment

To determine the assigned values and control ranges for Range+ 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 devices with data collection. Measurement of each parameter is performed alternately on the reference ampoule and the sample ampoule and repeated 12 times on each ABL7xx for a total of 144 measurements. Target ranges are calculated based on the mean ±2SD.

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7 Conclusion

The Range+ QUALICHECK Level 1, Level 2 and Level 3 are 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 and Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Public Health Service

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

March 15, 2013

Radiometer Medical Aps c/o Martin Gabler Regulatory Affairs Akandevej 21 2700 Bronshoj, Denmark

Re: K130236

Trade/Device Name: Range+ QUALICHECK, LEVEL 1 Range+ QUALICHECK, LEVEL 2 Range+ QUALICHECK, LEVEL 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJS Dated: January 24, 2013 Received: February 8, 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

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Page 2-Mr. Gabler

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.htm for 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/Resourcesfor You/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): K130236

Device Name: Range+ QUALICHECK, LEVEL 1 Range+ QUALICHECK, LEVEL 2 Range+ QUALICHECK, LEVEL 3

Indications for Use:

Analytes are: pH, pCO2, pO2, ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHbF , cK , cNa , cCa2+, cCI7, cGlu, cLac, ctBil

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)

Yung W.O.Chan-S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K130236 510(k)

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.