(32 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Liquichek Whole Blood Immunosuppressant Control, based on the provided document:
This document is a 510(k) submission for a quality control material, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, the "acceptance criteria" here relate to the stability and similar performance to a predicate device, rather than diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Claims) | Reported Device Performance |
|---|---|
| Open Vial Stability (Analyte Specific) | |
| Tacrolimus: Stable for 10 days at 2 to 8 °C | Tacrolimus: Stable for 10 days at 2 to 8 °C |
| All other analytes (Cyclosporine, Sirolimus, Everolimus): Stable for 14 days | All other analytes: Stable for 14 days at 2 to 8 °C |
| Shelf Life Stability | |
| Stable for 40 months at -20°C to -70°C | Stable for 40 months at -20°C to -70°C |
| 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 (Cyclosporine, Tacrolimus, Sirolimus, Everolimus). This matches the predicate device's intended use, with the addition of Everolimus. |
| Matrix Type | Whole Blood |
| (Implied) Performance Similarity to Predicate Device | The device "performs similarly" as the predicate device (Lyphochek Whole Blood Immunosuppressant Control, K072721). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the stability studies or other performance tests. It refers to "replicate analyses," implying multiple measurements were taken for the stability studies.
The data provenance is internal to Bio-Rad Laboratories, as stated in Section 8.0: "All supporting data is retained on file at Bio-Rad Laboratories." No country of origin is specified for the data itself, but the manufacturer is based in Irvine, California, USA. The studies appear to be prospective in nature, as they are establishing new stability claims for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is generally not applicable to the evaluation of a quality control material. The "ground truth" for a quality control material is its known concentration of analytes, established through highly controlled laboratory methods. Experts in the traditional sense (e.g., radiologists interpreting images) are not involved in setting the "ground truth" for chemical controls.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1 or 3+1) are typically used for studies involving subjective human interpretation, such as image reading. This is not relevant for the evaluation of a quality control material, where stability and analytical performance are measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., medical imaging AI). The Liquichek Whole Blood Immunosuppressant Control is a quality control material for laboratory instruments.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is also not applicable. This device is a control material, not an algorithm or a diagnostic test that produces results that require human interpretation or algorithmic processing. Its performance is evaluated by its chemical stability and its ability to deliver consistent results when run on an assay.
7. The Type of Ground Truth Used
The ground truth for this quality control material is its known concentration of analytes. This is established through the manufacturing process and confirmed by analytical testing using reference methods. For example, "Mean values for control levels 1-4 of each analyte, derived from replicate analyses, are listed in the package insert." This indicates that the expected values for the control are determined by the manufacturer through precise analytical measurements.
8. The Sample Size for the Training Set
This concept is not applicable. This product is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device, this question is not applicable.
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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
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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 BloodImmunosuppressant Control(New Device) | Lyphochek Whole BloodImmunosuppressant Control(Predicate Device, K072721) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek Whole BloodImmunosuppressant Control is intendedfor use as an assayed quality controlmaterial to monitor the precision oflaboratory testing procedures for theanalytes listed in the package insert. | Lyphochek Whole BloodImmunosuppressant Controls areintended for use as an assayed qualitycontrol material to monitor the precisionof laboratory testing procedures for theanalytes listed in the package insert. |
| Matrix | Whole Blood | Whole Blood |
| Open Vial Stability | Tacrolimus : 10 days at 2 to 8 °CAll 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 & FrozenStability | No claim | 30 days when stored at -20°C to -70°C |
| Analytes | Contains:CyclosporineTacrolimusSirolimusEverolimus | Contains:CyclosporineTacrolimusSirolimusDoes 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:
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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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Page 2
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
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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
Page 1 of 1
§ 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.