(44 days)
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No
The summary describes a quality control solution for in vitro diagnostic devices, not a device that processes data or makes decisions using AI/ML.
No
The device is an in vitro diagnostic quality control system used to evaluate the accuracy and precision of laboratory instruments, not to treat or diagnose patients.
No
This device is a quality control system used to evaluate the accuracy and precision of diagnostic devices. It does not perform diagnostic measurements itself.
No
The device description clearly states it is a "three level quality control system" consisting of "ampoules" containing a "solution." This indicates a physical, tangible product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use."
- Function: The device is described as an "assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges." This function of verifying the performance of diagnostic tests is a core characteristic of IVD quality control materials.
- Analytes: The list of analytes (pH, pCO2, pO2, ctHb, etc.) are parameters commonly measured in clinical diagnostic testing.
- Predicate Device: The mention of a predicate device (K980135 QUALICHECK5+) which is also a quality control material for diagnostic testing further supports its classification as an IVD.
N/A
Intended Use / Indications for 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+, gCl+, cGlu, cLac, ctBil
Product codes
JJS
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 21 |
| 2700 Broenshoej | |
| Denmark | |
| 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
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:
1
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 hours |
| at a constant temperature between 18 °C and 32 ° | ||
| before use. To maintain the reliability of the blood gas | ||
| parameters, you must use the contents of the ampoule | ||
| immediately after opening and according to the | ||
| instructions in the operator's manual for the relevant | ||
| analyser. | ||
| Blood Gas | ||
| Measurement | Same | pH, pO₂, pCO₂ |
| Oximetry | ||
| Measurement | Same | ctHb, sO₂ FO₂Hb, FCOHb, FMetHb |
| Electrolyte | ||
| Measurement | Same | cK⁺, cNa⁺, cCa²⁺, cCl⁻ |
| Metabolite | ||
| Measurement | Same | cGlucose, cLactate |
| Hemoglobin | ||
| Measurement | Same | ctBil |
| Compatible | ||
| analyzers | Same | ABL700/705/710/715/720/725/730/735 ABL805/810/815/820/825/830/835 ABL80 - OSM SW ABL90 FLEX |
2
.
| 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 date
5 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 Section
12.02 Target values | Target ranges, see Section
12.02 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.
.
3
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).
.. ·
4
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
5
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
6
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:
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+, 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)