(636 days)
Not Found
No
The document describes a control material for laboratory assays and does not mention any AI or ML components.
No
The device is an in vitro diagnostic control intended to verify the performance of laboratory assay systems for measuring immunosuppressants, not to directly treat or diagnose a condition.
No
The device is described as an "in vitro diagnostic device" but its intended use is to "verify performance of various laboratory assay systems," meaning it is a control product used with diagnostic devices, not a diagnostic device itself. The "Device Description" also specifies it is a "control" containing analytes.
No
The device is a lyophilized, multi-analyte human whole blood based product, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporin, tacrolimus, or sirolimus.
Product codes (comma separated list FDA assigned to the subject device)
LAS
Device Description
The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank.
Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet.
Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.
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
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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)
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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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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
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5. 510(k) Summary or 510(k) Statement
NOV 1 7 2009
510(k) Summary for Chromsystems MassCheck Immunosuppresants Whole Blood Controls
According to the requirements of 21CFR 807.92, the following information provides sufficient detail to understand the basis for determination of substantial equivalence.
Submitter Name, Address, and Contact Information:
Chromsystems Instruments and Chemicals GmbH, Heimburgstrasse 3, D- 82143 Munich, Germany Dr. Andreas Groemping, Regulatory Affairs Manager Phone: +49/89 18 930-200; Fax: +49/89 18 930-299
Device Name and Classification:
Proprietary Names:
MassCheck Immunosuppressants Whole Blood Controls (Level I-IV, Blank)
Classification name:
Drug specific control materials; Class I DIF (91 Toxicology) 21 CFR 862.3280
Common/Usual names: Immunosuppressants Control Material
Predicate Devices:
Bio-Rad Laboratories Lyphochek Whole Blood Immunosuppressant Control (K072721) Waters MassTrak™ Immunosuppressants Kit (K063868)
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Device Description:
The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank.
Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet.
Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.
Intended Use:
MassCheck Immunosuppresants Whole Blood Controls (Level I-TV and Blank)
The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.
Substantial Equivalence Information:
The predicate and proposed devices are similar in the following ways:
- Same intended use in vitro diagnostic devices intended for the . calibration and control of laboratory assay systems used in the determination of immunosuppressant specific drug analytes in patient whole blood.
- Same analytes .
- Consist of similar matrices (human whole blood) .
- Predicates and proposed devices are supplied lyophilized and must . be reconstituted
These devices differ in the following ways:
- The numbers of concentration levels are different. ●
The Chromsystems MassCheck Immunosuppressants Controls are substantially equivalent to predicate devices which are currently legally marketed via the 510(k) process intended for similar use, as demonstrated by the information provided in this premarket notification.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Chromsystems Instruments and Chemicals GMBH C/O Cathy Cambria Arkin Consulting Group 1733 Canton Lane Suite 103 Marietta, Georgia 30062-2679
NOV 1 7 2009
Re: K080459
Trade Name: MassCheck Immunosuppressant Whole Blood Controls (Level I-IV plus Blank) Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: Class I Product Codes: LAS Dated: November 2, 2009 Received: November 6, 2009
Dear Ms. Cambria:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement Indication for Use
510(k) Number (if known): K080459
Device Name: MassCheck Immunosuppresants Whole Blood Controls (Level I-IV plus Blank)
Intended Use:
The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.
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 Diagnostic Device Evaluation and Safety (OVD)
 K080459