(41 days)
Not Found
No
The description focuses on a quality control material for laboratory testing and does not mention any AI or ML components.
No
This device is a quality control material intended to monitor the precision of laboratory procedures for cyclosporine testing, not to treat or diagnose a disease.
No
This device is a quality control material intended to monitor the precision of laboratory procedures for cyclosporine testing, not to diagnose a patient's condition.
No
The device description explicitly states the product is prepared from human whole blood and provided in lyophilized form, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory procedures for cyclosporine testing." This is a classic function of an IVD - to ensure the accuracy and reliability of diagnostic tests performed in a laboratory setting.
- Device Description: The description mentions it's prepared from "human whole blood" and is used in "laboratory procedures." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body.
- Anatomical Site: The anatomical site is "whole blood," which is a human specimen.
- Intended User / Care Setting: The intended user is "laboratory procedures," indicating it's used in a clinical laboratory environment.
While it's a quality control material rather than a test that directly diagnoses a condition, quality controls are considered IVDs because they are essential components of the overall in vitro diagnostic process. They are used to ensure the validity of the results obtained from diagnostic tests.
N/A
Intended Use / Indications for Use
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
This product is prepared from human whole blood with added chemicals and preservatives. This product is provided in lyophilized form for added stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory procedures
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 have been performed to determine the open vial stability and shelf life for the Lyphochek Elevated Immunosuppressant Control. Product claims and a summary of the protocols used to establish claims are as follows:
- . Open vial Stability: 14 days when stored tightly capped at 2 to 8°C.
- After reconstituting and freezing: 30 days when stored tightly capped at -- 10 to -20°C. .
- . Shelf Life: Three years and three months when stored at 2 to 8 °C
Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.
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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§ 862.1660 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.
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Summary of Safety and Effectiveness Lyphochek Elevated Immunosuppressant Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road. Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367 Date of Summary Preparation
August 20, 2004
2.0 Device Identification
| Product Trade Name: | Lyphochek Elevated Immunosuppressant Control |
|---|---|
| Common Name: | Multi-analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 864.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Lyphochek Whole Blood Control Bio-Rad Laboratories Irvine, California
510 (k) Number: K022041
4.0 Description of Device
This product is prepared from human whole blood with added chemicals and preservatives. This product is provided in lyophilized form for added stability.
5.0 Intended Use
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
6.0 Preservatives:
The Lyphochek Elevated Immunosuppressant Control does not contain sodium azide as a preservative. It contains a broad-spectrum anti-microbial cocktail as a preservative where the concentration of any one incredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic
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and international regulations do not require this type of information on the vial or box label.
7.0 Comparison of the new device with the Predicate Device
Lyphochek Elevated Immunosuppressant Control claims substantial equivalence to the Lyphochek Whole Blood Control currently in commercial distribution (K022041).
| Bio-Rad Laboratories | Bio-Rad Laboratories | |
|---|---|---|
| Characteristics | Lyphochek Elevated Immunosuppressant | |
| Control | ||
| (New Device) | Lyphochek Whole Blood Control | |
| (Predicate Device K022041) | ||
| Similarities | ||
| Intended Use | Lyphochek Elevated Immunosuppressant Control is | |
| intended for use as a whole blood quality control to monitor | ||
| the precision of laboratory procedures for cyclosporine | ||
| testing. | Lyphochek Whole Blood 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. | ||
| Form | Lyophilized | Lyophilized |
| Matrix | Processed Human Whole Blood Lysate | Processed Human Whole Blood Lysate |
| Preservatives | Contains preservatives | Contains preservatives |
| Storage (Unopened) | 2°C to 8°C | |
| Until expiration date | 2°C to 8°C | |
| Until expiration date | ||
| Reconstituted Vial | ||
| Claim | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C |
| After Reconstituting | ||
| and Freezing | After reconstituting and freezing, the product will be | |
| stable for 30 days when stored tightly capped at | ||
| -10 to -20°C. | After reconstituting and freezing the control, all analytes | |
| will be stable for 30 days when stored tightly capped at | ||
| -10 to -20°C. | ||
| Differences | ||
| Levels | Bi-level (Levels 4 and 5) | Tri-level (Levels 1, 2 and 3) |
| Analytes | Contains the following analyte: | |
| • Cyclosporine | ||
| Does not contain the following analytes: | ||
| • Lead | ||
| • Red Cell Folate | ||
| • Tacrolimus | ||
| • Sirolimus | Contains the following analytes: | |
| • Cyclosporine | ||
| • Lead | ||
| • Red Cell Folate | ||
| • Tacrolimus | ||
| • Sirolimus |
Table 1. Similarities and Differences between new and predicate device.
8.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek Elevated Immunosuppressant Control. Product claims and a summary of the protocols used to establish claims are as follows:
- . Open vial Stability: 14 days when stored tightly capped at 2 to 8°C.
- After reconstituting and freezing: 30 days when stored tightly capped at -- 10 to -20°C. .
- . Shelf Life: Three years and three months when stored at 2 to 8 °C
Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
OC] 7 - 2004
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs Manager/ Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K042324
Trade/Device Name: Lyphochek Elevated Immunosuppressant Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 20, 2004 Received: August 27, 2004
Dear Ms. Platt:
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).
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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. 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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Indications for Use
510(k) Number (if known):
Device Name:
Lyphochek Elevated Immunosuppressant Control
Indications For Use:
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
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)
Page 1 of
Alberto Suti
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K011324