(86 days)
Not Found
No
The document describes a liquid quality control system and does not mention any AI or ML components or functionalities.
No.
The device is a quality control system for analytical instruments, not for diagnosis, treatment, or prevention of disease in humans.
No
Explanation: The device is described as a quality control system for checking the precision and accuracy of medical analyzers. It does not directly diagnose a patient's condition.
No
The device description explicitly states it is a "liquid four ampoule quality control system" and lists physical part numbers (S7835, S7845, S7855, S7865) which are described as "30 ampoules per box." This indicates a physical, liquid-based product, not a software-only device.
Yes, based on the provided information, the AutoCheck6+ is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's a "quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine." These are all parameters measured in biological samples (blood, etc.) in vitro (outside the body).
- Device Description: It's a "liquid four ampoule quality control system," which is a typical format for IVD quality control materials.
- Predicate Devices: The listed predicate devices (QUALICHECK5+ and AutoCheck5+) are also quality control systems for similar parameters, strongly indicating that this type of device is classified as an IVD.
Quality control materials used to verify the performance of diagnostic tests performed on biological samples are considered IVDs.
N/A
Intended Use / Indications for Use
The AutoCheck6+ is a liguid four ampoule quality control system for checking the precision and accuracy of Radiometer analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.
me AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.
Product codes
JJY
Device Description
AutoCheck6+ is a four level quality control system consisting of part numbers S7835, S7845, S7855, and S7865. Each level consists of 30 ampoules per box.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
K051928 - 510(k) Premarket Notification; AutoCheck6+
OCT 1 2 2005
September 29, 2005
510(k) Summary
| Submitter: | Radiometer Medical ApS |
|---|---|
| Address: | Åkandevej 21, DK-2700 Brønshøj, Denmark |
| Phone: | +45 3827 3827 or +45 3827 3390 (direct) |
| Fax: | +45 3827 2736 |
| Contact Person: | Ms. Kirsten Rønø |
| Date Summary Prepared: | September 29, 2005 |
| Device Trade Name: | AutoCheck6+ |
| Common name: | Quality Control |
| Classification Name: | Quality Control Material (Assayed and Unassayed) |
| (21 CFR Section 862, 1660) |
Predicate Devices
QUALICHECK5+ (K980135) and AutoCheck5+ (part of K992859 - ABL7000 with AutoCheck Module).
Device Description
AutoCheck6+ is a four level quality control system consisting of part numbers S7835, S7845, S7855, and S7865. Each level consists of 30 ampoules per box.
Intended Use
The AutoCheck6+ is a liguid four ampoule quality control system for checking the precision and accuracy of Radiometer analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.
Technology
AutoCheck6+ is technically similar to the predicate device QUALICHECK5+ and AutoCheck5+. The AutoCheck6+ solutions are aqueous solutions that have the same components as QUALICHECK5+ and AutoCheck5+ and in addition hereto there is added specific amounts of creatine and creatinine and also of the enzyme creatininase (creatinine amidohydrolase) which stabilizes the equilibrium between creatine and creatinine. The measuring of the AutoCheck6+ is performed equivalent to the measuring of the QUALICHECK5+ and AutoCheck5+.
Predicate Devices; Substantial Equivalence
The AutoCheck6+ is substantially equivalent in features and characteristics to the predicate devices QUALICHECK5+ (K980135) and AutoCheck5+ (part of K992859 - ABL7000 with AutoCheck Module) manufactured by Radiometer Medical ApS. The major difference is the addition of the creatinine (cCrea) analyte.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Public Health Service
OCT 1 2 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kirsten Rønø Director of Quality and Regulatory Affairs Radiometer Medical ApS Åkandevej 21 DK-2700 Brønshøj Denmark
K051928 Trade/Device Name: AutoCheck6+ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 2, 2005 Received: September 7, 2005
Dear Ms. Rønø:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
2
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
K051928 - 510(k) Premarket Notification; AutoCheck6+
RADIOMETER COPENHAGEN
September 29, 2005
Indications for Use
K051928 510(k) Number:
AutoCheck6+ Device Name:
Intended Use:
me AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ruta C. heuler
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k) K051928