CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

Device Description

CueSee® Hypoxic is prepared from a stroma-free bovine hemoglobin solution and provides the oxygen buffering characteristics of fresh whole blood. The concentrations of total hemoglobin and acid-base levels are within the normal physiological range. Tonometry with a predetermined level of oxygen balanced with nitrogen provides a distinct assay value for partial pressure of oxygen measurements. CueSee® Hypoxic contains no preservatives, viscosity adjusters or other additives that might adversely effect electrode measurements.

CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution.

CueSee® Hypoxic is packed in a carton box containing 5 ampules.

AI/ML Overview

The provided text describes the 510(k) submission for the CueSee® Hypoxic device, a quality control material for blood gas analyzers. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for a diagnostic (e.g., accuracy, sensitivity, specificity for a medical condition).

Therefore, the document does not contain the information required to populate a table of acceptance criteria and device performance or describe a study for a diagnostic device in the sense of accuracy, sensitivity, or specificity. The "study" described is primarily about establishing stability and value assignment for a quality control material.

However, I can extract the relevant information regarding the product's characteristics and the tests performed to support its claims as a quality control material.

Here's what can be extracted and how it relates to the given prompt, with explanations for what is not present:

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

The document doesn't provide a typical "acceptance criteria" table for diagnostic performance (e.g., sensitivity, specificity, accuracy against a disease state). Instead, it discusses stability and value assignment as key performance aspects for a quality control material.

Characteristic	Acceptance Criteria (Implicit for QC Material)	Reported Device Performance (as a QC material)
Stability (Sealed Ampule)	Must maintain integrity and assigned values over time.	31 days at 2-8°C
Stability (Open Vial)	Must maintain integrity and assigned values for a short period after opening.	10 minutes
Value Assignment (pO2)	Values must be assignable and reproducible for monitoring blood gas analyzers.	Lot specific values determined by the mean of multiple determinations on randomly selected samples; Ranges assigned using pre-determined intervals.
Traceability	Values should be traceable to a recognized standard.	Traceable to NIST SRM: 2658a (for pO2)

Notes:

For a quality control material, the "performance" isn't about diagnosing a condition, but rather accurately reflecting a known concentration or value to allow verification of a diagnostic instrument.
The document implies that the device "meets" its purpose by demonstrating these characteristics, which are standard for quality control materials.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for specific tests (e.g., stability or value assignment). For value assignment, it mentions "multiple replicates of test samples" and "mean of multiple determinations performed on randomly selected samples from each lot," but no specific number.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's implied to be internal testing by the manufacturer (Eurotrol B.V., Netherlands).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this document. For a quality control material, the "ground truth" (or assigned value) is established through rigorous internal testing against reference materials using validated methods, not typically by expert consensus in clinical interpretation.

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

Not applicable as the "ground truth" for a QC material's value assignment is based on metrology and analytical chemistry, not clinical 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:

Not applicable. This is a quality control material, not an AI-based diagnostic tool requiring human reader studies.

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

Not applicable. This is a physical quality control material, not an algorithm. Its "standalone performance" refers to its ability to yield consistent and accurate pO2 values when measured correctly. The document describes protocols for how these values are determined (section "12. Value Assignment").

7. The type of ground truth used:

For Value Assignment (pO2): Traceability to NIST SRM: 2658a (National Institute of Standards and Technology Standard Reference Material). This is a metrological ground truth derived from international standards, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is a quality control material, not an AI model or a device that requires "training."

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

Not applicable. As above, there's no "training set." The values of the QC material are established by direct measurement on a calibrated blood gas analyzer and traceable to a NIST Standard Reference Material.

Summary of Device and Study Focus:

The device, CueSee® Hypoxic, is a quality control material (Class I, reserved), not a diagnostic device that directly interprets patient data. Its primary purpose is to monitor the performance of blood gas analyzers for Oxygen partial pressure (pO2).

The "study" or evidence provided in the 510(k) summary focuses on demonstrating:

Its intended use as a quality control material for pO2.
Its composition and physical characteristics (e.g., bovine hemoglobin solution, 2.5 mL volume, liquid form).
Its stability (31 days un-opened, 10 minutes opened).
Its value assignment method (multiple replicates, mean determination, lot-specific values).
Its traceability to a recognized standard (NIST SRM 2658a for pO2).
Its substantial equivalence to a predicate device (RNA Medical® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control) in terms of fundamental scientific technology, features, and characteristics, despite some differences (e.g., number of levels, analytes covered).

The provided text details the regulatory clearance for a quality control material, not an AI/diagnostic device that processes patient data and requires typical clinical performance metrics like sensitivity, specificity, or reader studies.

Summary

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

EUROTROL B.V. MARGHERITA LA MARCA REGULATORY AFFAIRS MANAGER KEPLERLAAN 20 EDE 6716 BS NETHERLANDS

April 22, 2016

Re: K152553

Trade/Device Name: Cuesee Hypoxic Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I. Reserved Product Code: JJS Dated: March 22, 2016 Received: March 24, 2016

Dear Ms. La Marca:

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 (OS) 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/ResourcesforYou/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,

Katherine Serrano -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) K152553

Device Name CueSee® Hypoxic

Indications for Use (Describe)

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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. This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

2. Submitter

Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands T +31 318 695777 F +31 318 695770 E office@eurotrol.com

3. Submitter Contact

Margherita La Marca QA/RA Manager Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands T +31 318 695777 F +31 318 695770 E mlamarca@eurotrol.com

4. Device identification

Proprietary Name: CueSee® Hypoxic Common Name: Blood gas control Classification Name: Class I, reserved Product code: JJS; Controls for blood-gases, (assayed and unassayed) (21 CFR 862.1660)

5. Predicate Device

Device Name: RNA Medical® Brand QC 823 Range Blood Gas Electrolyte Metabolite Control Manufacturer: Bionostics, Inc., 510(k) number: K032453, Decision Date: 08/28/2003

6. Intended Use

CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2).

Device description 7.

CueSee® Hypoxic provides one level in the critical low pO2 value range, each ampule holding 2.5 mL of solution.

CueSee® Hypoxic is packed in a carton box containing 5 ampules.

8. Special Instrument Required

For an appropriate use of CueSee® Hypoxic the use of a blood gas analyzer is required.

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9. Predicate Device Comparison

Comparison of CueSee® Hypoxic to the predicate device for substantial equivalence:

	New Device	Predicate Device
	CueSee® Hypoxic	RNA Medical Brand QC 823 RangeBlood Gas Electrolyte MetaboliteControl
510(k), date		K032453, 08/28/2003
Number oflevels	1	2
Analytes	pO2	pH, pCO2, pO2, Ca++, Na+, K+, Cl+,Mg++, Glucose, Lactate
Value range	pO2: 15 - 25 mmHg	pO2: 8 - 69 mmHg (Level 0)
Container	Clear glass ampules	Clear glass ampules
Filling Volume	2,5 mL	2,5 mL
Color	Blood like	Colorless
Storagetemperature	2-8 °C / 35-46°F	2-8 °C / 35-46°F or9-25 °C / 35-77°F
Indications forUse	Performance assessment of the criticallow pO2 value range of blood gasanalyzers.	Monitoring the performance of blood gas,electrolyte, and metaboliteinstrumentation.
Matrix/Materials	Pre-tonometered solution of bovineoxyhemoglobin (O2Hb) of purifiedstroma-free bovine hemoglobin	Buffered aqueous solution containingelectrolytes (Na+, K+, Cl-, Ca++, Mg++),glucose, and lactate. It has beenequilibrated with specificlevels of CO2, O2, and N2.
Form	Liquid	Liquid
Open VialStability	10 minutes	For pH/blood gas values measureimmediately after opening
Values	Lot specific	Lot specific
Shelf life	31 days at 2-8 °C	36 months at 2-8 °C9 months at 2-25 °C
Where used	Clinical Laboratories, Point of Caretesting	Clinical Laboratories, Point of Care testing

Table 1. Predicate Device Comparison

10. Standards and guidelines reference

CLSI EP25-A; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, Vol 29, । No. 20, September 2009:
Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer l Untersuchungen (RiLiBAEK), Deutschen Ärzteblatt Jg.110, Heft 12, 22.03.2013, Seite A 575-582.

11. Stability

Real time stability studies have been performed for CueSee® Hypoxic.

The claimed stability is 31 days when the product is stored at 2-8°C. After opening of the ampule, the product is stable for 10 minutes.

12. Value Assignment

Multiple replicates of test samples are measured at the beginning and end of the production run on blood gas analyzers for pO2 values.

Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Ranges are assigned using pre-determined intervals. Value assignment is performed for each lot of CueSee® Hypoxic.

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13. Traceability

The different levels of CueSee® Hypoxic are traceable to the reference material as shown in the table below.

Analyte	Reference Material
pO2	NIST SRM: 2658a

14. Conclusion

We recommend that CueSee® Hypoxic is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate device: RNA Medical Brand QC 823 Range Blood Gas Electrolyte Metabolite Control (K032453)

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.