(227 days)
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No
The description focuses on the chemical composition and physical properties of a quality control material for blood gas analyzers. There is no mention of algorithms, data processing, or learning capabilities.
No
The device is a quality control material intended for monitoring blood gas analyzers' performance, not for treating or diagnosing patients.
No
Explanation: CueSee® Hypoxic is a quality control material used to monitor the performance of blood gas analyzers, not a diagnostic device itself. It does not diagnose any disease or condition in a patient.
No
The device description clearly indicates it is a physical quality control material (a solution in ampules) for blood gas analyzers, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is for "monitoring blood gas analyzers' performance of Oxygen partial pressure (pO2)." This indicates it is used in vitro (outside the body) to assess the accuracy and reliability of a diagnostic device (the blood gas analyzer).
- Device Description: It is a "quality control material" used to check the performance of a diagnostic instrument.
- Professional Use: It is intended for "professional use" in settings like "Clinical Laboratories, Point of Care testing," which are typical environments for IVD use.
Quality control materials like CueSee® Hypoxic are considered IVDs because they are essential components in ensuring the accuracy and reliability of diagnostic tests performed in vitro. They are used to verify that the analytical system (in this case, the blood gas analyzer) is functioning correctly and producing accurate results.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
JJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use; Clinical Laboratories, Point of Care testing
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
-
- 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 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.
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 Range | |
| Blood Gas Electrolyte Metabolite | ||
| Control | ||
| 510(k), date | K032453, 08/28/2003 | |
| Number of | ||
| levels | 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 |
| Storage | ||
| temperature | 2-8 °C / 35-46°F | 2-8 °C / 35-46°F or |
| 9-25 °C / 35-77°F | ||
| Indications for | ||
| Use | Performance assessment of the critical | |
| low pO2 value range of blood gas | ||
| analyzers. | Monitoring the performance of blood gas, | |
| electrolyte, and metabolite | ||
| instrumentation. | ||
| Matrix/ | ||
| Materials | Pre-tonometered solution of bovine | |
| oxyhemoglobin (O2Hb) of purified | ||
| stroma-free bovine hemoglobin | Buffered aqueous solution containing | |
| electrolytes (Na+, K+, Cl-, Ca++, Mg++), | ||
| glucose, and lactate. It has been | ||
| equilibrated with specific | ||
| levels of CO2, O2, and N2. | ||
| Form | Liquid | Liquid |
| Open Vial | ||
| Stability | 10 minutes | For pH/blood gas values measure |
| immediately after opening | ||
| Values | Lot specific | Lot specific |
| Shelf life | 31 days at 2-8 °C | 36 months at 2-8 °C |
| 9 months at 2-25 °C | ||
| Where used | Clinical Laboratories, Point of Care | |
| testing | 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)