(32 days)
Not Found
No
The device is a quality control material for laboratory testing and the description focuses on its composition, stability, and intended use for monitoring precision, with no mention of AI or ML technologies.
No
The device is a quality control material used to monitor the precision of laboratory testing procedures for immunosuppressant analytes, not to directly treat or diagnose a disease or condition.
No
This device is described as an "assayed quality control material" intended "to monitor the precision of laboratory testing procedures." Its purpose is to ensure the accuracy of assays for immunosuppressant analytes, not to directly diagnose a patient's condition.
No
The device is a quality control material prepared from human whole blood, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description mentions it's prepared from human whole blood and used in "laboratory testing procedures."
- Analytes: The listed analytes (Sirolimus, Tacrolimus, Cyclosporine, Everolimus) are commonly measured in clinical laboratories to monitor patients receiving immunosuppressant therapy.
- Quality Control Material: The product is explicitly described as an "assayed quality control material," which is a type of IVD used to ensure the accuracy and reliability of diagnostic tests.
- Predicate Device: The mention of a predicate device (K072721; Lyphochek Whole Blood Immunosuppressant Control) further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
Therefore, based on the provided information, the Liquichek Whole Blood Immunosuppressant Control fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Sirolimus, Tacrolimus, Cyclosporine, Everolimus.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
This product is prepared from human whole blood with added preservatives and stabilizers. The control is provided in liquid form for convenience. Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert. Each laboratory should establish its own means and acceptable ranges based on their own test system and tolerance limits.
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
laboratory
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)
Stability studies have been performed for Liquichek Whole Blood Immunosuppressant control to determine the open vial stability and shelf life claims.
Key Results:
- Open Vial Stability: Tacrolimus will be stable for 10 days at 2 to 8 °C. All other analytes will be stable for 14 days.
- Shelf Life Stability: 40 months at -20°C to -70° C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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.
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Summary of Safety and Effectiveness Liquichek Whole Blood Immunosuppressant control
MAY 1 8 2012
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road Irvine California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467
Date of Summary Preparation
May 17, 2012
2.0 Device Identification
Liguichek Whole Blood Immunosuppressant Control Product Trade Name: Drug Mixture Control Materials Common Name: Class I, Reserved Classifications: DIF Product Code: 21 CFR 862.3280 Regulation Number:
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek Whole Blood Immunosuppressant Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K072721
Description of Device 4.0
This product is prepared from human whole blood with added preservatives and stabilizers. The control is provided in liquid form for convenience.
Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert. Each laboratory should establish its own means and acceptable ranges based on their own test system and tolerance limits.
5.0 Intended Use
Confidential
1
Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Comparison of the new device with the Predicate Device 6.0
Table 1: Similarities and Differences between new and predicate device
| Characteristics | Liquichek Whole Blood
Immunosuppressant Control
(New Device) | Lyphochek Whole Blood
Immunosuppressant Control
(Predicate Device, K072721) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Whole Blood
Immunosuppressant Control is intended
for use as an assayed quality control
material to monitor the precision of
laboratory testing procedures for the
analytes listed in the package insert. | Lyphochek Whole Blood
Immunosuppressant Controls are
intended for use as an assayed quality
control material to monitor the precision
of laboratory testing procedures for the
analytes listed in the package insert. |
| Matrix | Whole Blood | Whole Blood |
| Open Vial Stability | Tacrolimus : 10 days at 2 to 8 °C
All other analytes: 14 days at 2 to 8 °C | 14 days at 2 to 8 °C (reconstituted) |
| Shelf Life Storage & Stability | Until expiration date at -20°C to -70°C | Until expiration date at -20°C to -70°C |
| Differences | | |
| Form | Liquid | Lyophilized |
| Reconstituted & Frozen
Stability | No claim | 30 days when stored at -20°C to -70°C |
| Analytes | Contains:
Cyclosporine
Tacrolimus
Sirolimus
Everolimus | Contains:
Cyclosporine
Tacrolimus
Sirolimus
Does not contain:
Everolimus |
Statement of Supporting Data 7.0 ·
Stability studies have been performed for Liquichek Whole Blood Immunosuppressant control to determine the open vial stability and shelf life claims. Product claims are as follows:
| 7.1 | Open Vial Stability: Tacrolimus will be stable for 10 days at 2 to 8 °C. All other analytes will be stable for 14 days. |
|---|---|
| ----- | ------------------------------------------------------------------------------------------------------------------------- |
40 months at -20°C to -70° C 7.2 Shelf Life Stability:
2
8.0 Conclusion
. .
.
.
·
Liquichek Whole Blood Immunosuppressant Control is intended to be used for the same purposes as the predicate device. It has the whole blood matrix and performs similarly as the predicate device.
All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Bio-Rad Laboratories c/o Suzanne Parsons Regulatory Affairs/QA/QC Manager 9500 Jeronimo Road Irvine, CA 92618-2017, USA
MAY 1 8 2012
K121143 Re:
Trade Name: Liquichek Whole Blood Immunosuppressant Control Regulation Number: 21 CFR §862.3280 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Codes: DIF Dated: April 12, 2012 Received: April 16, 2012
Dear Ms. Parsons:
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 moun that 1 Dr mas mass 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/Medical
Devices/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/Resourcesfor You/Industry/default.htm
Sincerely yours,
N
Courtney H. Lias, Ph.D.
Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K121143
Device Name:
Liquichek Whole Blood Immunosuppressant Control
Indications for Use:
Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are listed in the package insert:
-
Sirolimus
- Tacrolimus
- Cyclosporine
- Everolimus
Prescription Use × (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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K) K12 11 43
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