(41 days)
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
This product is prepared from human whole blood with added chemicals and preservatives. This product is provided in lyophilized form for added stability.
This document describes the Lyphochek Elevated Immunosuppressant Control, a quality control material for cyclosporine testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary focuses on establishing substantial equivalence to a predicate device and stability claims. It does not present specific quantitative "acceptance criteria" in terms of performance metrics (like accuracy, precision, or bias) for cyclosporine testing itself, as it is a quality control material, not a diagnostic test. Instead, the "acceptance criteria" for this device relate to its stability and its comparison to a similar existing product.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Status |
|---|---|---|
| Intended Use Equivalence | To be used as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing. (Similar to predicate) | Substantially Equivalent: Lyphochek Elevated Immunosuppressant Control is intended for the same purpose as the predicate device (Lyphochek Whole Blood Control), specifically tailored for cyclosporine. |
| Form Equivalence | Lyophilized (Similar to predicate) | Substantially Equivalent: New device is lyophilized, matching the predicate. |
| Matrix Equivalence | Processed Human Whole Blood Lysate (Similar to predicate) | Substantially Equivalent: New device uses processed human whole blood lysate, matching the predicate. |
| Preservation Equivalence | Contains preservatives (Similar to predicate) | Substantially Equivalent: New device contains a broad-spectrum anti-microbial cocktail as a preservative, similar to the predicate. (Note: New device explicitly states it does not contain sodium azide, which is a specification rather than a direct criterion match, but it still has preservatives). |
| Storage (Unopened) | 2°C to 8°C until expiration date (Similar to predicate) | Reported Performance: Three years and three months when stored at 2 to 8 °C. Study: Real-time studies are ongoing to support this claim. |
| Reconstituted Vial Claim | 14 days at 2°C to 8°C (Similar to predicate) | Reported Performance: 14 days when stored tightly capped at 2 to 8°C (Open vial Stability). Study: Stability studies performed. |
| Reconstituted and Freezing | 30 days when stored tightly capped at -10 to -20°C (Similar to predicate) | Reported Performance: 30 days when stored tightly capped at -10 to -20°C (After reconstituting and freezing). Study: Stability studies performed. |
| Safety | Preservative concentration not expected to cause a health hazard; does not contain sodium azide. | Reported Performance: Broad-spectrum anti-microbial cocktail has individual ingredient concentrations less than 0.1%, not expected to cause a health hazard. Does not contain sodium azide. This meets regulatory expectations for safety regarding preservatives at these low concentrations. |
| Substantial Equivalence | Demonstrates equivalence in terms of intended use, technological characteristics, and safety and effectiveness, despite minor differences (levels, specific analytes). | FDA Determination: FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This implies that the differences (bi-level vs. tri-level, specific analytes other than cyclosporine) were deemed not to raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the "sample size used for the test set" in the context of typical algorithm validation (e.g., number of patient samples). The studies performed are stability studies and a comparison against a predicate device.
- Stability Studies: The "sample size" for these would refer to the number of control vials tested at various time points and storage conditions. This information is not detailed in the summary.
- Data Provenance: The studies were performed by the manufacturer, Bio-Rad Laboratories, and the data is internal to the company. The summary states "All supporting data is retained on file at Bio-Rad Laboratories." There is no mention of country of origin for the data or whether it was retrospective or prospective, other than the "real-time studies will be ongoing" for shelf life, indicating a prospective approach for that specific claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this device. The Lyphochek Elevated Immunosuppressant Control is a quality control material, not a diagnostic device that requires expert interpretation of results or establishing a clinical ground truth. Its performance relates to its stability and its ability to consistently produce known (assigned) values for cyclosporine testing method monitoring. There are no "experts" establishing ground truth in the sense of clinical diagnosis.
4. Adjudication Method for the Test Set
This is not applicable to this device. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple readers or experts provide interpretations that need to be resolved to form a definitive ground truth. As noted above, this device does not involve such human interpretation or ground truth establishment.
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 imaging or similar devices where human readers interpret patient cases, and the AI's impact on their performance is being evaluated. The Lyphochek control is a material used to monitor an assay's precision, not a device that human readers interact with for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
N/A. This device is a physical quality control material, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for it.
7. The Type of Ground Truth Used
For this device, the "ground truth" (or reference value) would be the assigned value of cyclosporine within the control material, established through a robust method (e.g., highly accurate reference method or a consensus of multiple clinical analyzers). The document does not explicitly detail how these assigned values are derived or what type of "ground truth" is used for the values themselves, but rather focuses on the stability of these values over time and storage conditions. The "ground truth" for the stability claims is the manufacturer's internal criteria for acceptable variation from specified values under different conditions.
8. The Sample Size for the Training Set
This is not applicable to this device. There is no "training set" as this is not an AI/ML algorithm or a device that learns from data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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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 ImmunosuppressantControl(New Device) | Lyphochek Whole Blood Control(Predicate Device K022041) |
| Similarities | ||
| Intended Use | Lyphochek Elevated Immunosuppressant Control isintended for use as a whole blood quality control to monitorthe precision of laboratory procedures for cyclosporinetesting. | Lyphochek Whole Blood Control is intended for use as anassayed quality control material to monitor the precision oflaboratory testing procedures for the analytes listed in thepackage 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°CUntil expiration date | 2°C to 8°CUntil expiration date |
| Reconstituted VialClaim | 14 days at 2°C to 8°C | 14 days at 2°C to 8°C |
| After Reconstitutingand Freezing | After reconstituting and freezing, the product will bestable for 30 days when stored tightly capped at-10 to -20°C. | After reconstituting and freezing the control, all analyteswill 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:• CyclosporineDoes 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
§ 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.