(35 days)
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Lyphochek® Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyphochek® Tumor Marker Control.
Important Note: The provided document is a 510(k) Summary, which is a premarket notification for a medical device. It's meant to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily a comprehensive clinical study report. Therefore, some of the requested information (like multi-reader multi-case studies, effect sizes of AI assistance, detailed expert qualifications, or extensive training set information) is typically not found in this type of submission for this specific device. The device itself is a quality control serum, not an AI-powered diagnostic tool.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control serum, "acceptance criteria" usually refer to the stability claims that the product must meet to be considered effective for its intended use. The "reported device performance" is how the device actually performs against these claims during stability studies.
| Acceptance Criterion (Claim) | Reported Device Performance (as demonstrated by stability studies) |
|---|---|
| Open Vial Stability (2-8°C): | Met: |
| - All analytes stable for 14 days. | - All analytes stable for 14 days when stored tightly capped at 2-8°C. |
| - Exceptions: | - Exceptions: |
| - Ferritin and CA 27-29 stable for 6 days. | - Ferritin and CA 27-29 stable for 6 days. |
| - ACTH, Free PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. | - ACTH, Free PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. |
| - (Predicate: Ferritin and CA 27-29 stable for 14 days) | |
| Reconstituted Freeze-Thaw Stability (-10°C to -20°C): | Met: |
| - All analytes stable for 30 days. | - All analytes stable for 30 days when stored tightly capped at -10°C to -20°C. Once thawed, do not refreeze; discard remaining material. |
| - (Predicate: PSA stable for 20 days; ACTH and Calcitonin no frozen stability claims) | |
| Shelf Life (Unopened, 2-8°C): | Met: |
| - Control stable for 3 years and 3 months. | - Control stable for 3 years and 3 months when stored unopened at 2-8°C. (Real-time studies are ongoing to support shelf life.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the stability studies. It states "Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Tumor Marker Control." The nature of these studies typically involves multiple vials across different lots and time points, but the exact number is not provided.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories ("All supporting data is retained on file at Bio-Rad Laboratories"). The country of origin for the data is implicitly the United States, given Bio-Rad's location (Irvine, California) and the submission to the U.S. FDA. The studies are prospective in nature, as they involve testing the product over time to establish stability claims.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a quality control material's stability isn't established by expert consensus or interpretation of images; rather, it's determined through analytical testing using validated methods to measure analyte concentrations over time and under various storage conditions. The "ground truth" is the actual measured concentration, and the acceptance criteria define the acceptable deviation from the initial measurement.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and study. Adjudication methods like "2+1" or "3+1" are typically used in clinical trial settings where subjective interpretations (e.g., image reading) need to be resolved. For stability studies involving quantitative chemical measurements, the data is typically analyzed statistically against predetermined analytical criteria, not through expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The Lyphochek® Tumor Marker Control is a quality control serum used to monitor the precision of laboratory testing procedures (e.g., for tumor marker assays). It is not an AI-powered diagnostic device, nor does it involve human readers interpreting images or data that would typically be subject to MRMC studies or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical quality control material, not an algorithm.
7. The Type of Ground Truth Used
As mentioned in point 3, the "ground truth" in this context refers to the analytical measurements of analyte concentrations over time and under specific storage conditions. These measurements are performed using validated laboratory methods on the control material. The stability claims are then established based on whether these measurements remain within pre-defined acceptable ranges over the claimed duration.
8. The Sample Size for the Training Set
This information is not applicable. Quality control materials typically undergo stability testing rather than having a "training set" in the machine learning sense. The initial formulation and characterization might involve many experiments, but it's not analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in points 3 and 8. The "ground truth" for the performance of the control material is established through rigorous analytical testing and adherence to good manufacturing practices (GMP) and quality system regulations (QS).
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JUN 2 6 2001
Summary of Safety and Effectiveness Lyphochek® Tumor Marker Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
Contact Person
Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
May 18, 2001
2.0 Device Identification
Lyphochek® Tumor Marker Control Product Trade Name:
Multi-Analyte Controls, (Assayed and unassayed) Common Name:
| Classifications: | Class I |
|---|---|
| Product Code: | 75JJY |
| Regulation Number: | CFR 862.1660 |
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek® Tumor Marker Control Bio-Rad Laboratories Irvine, California
Docket Number: K992172
4.0 Description of Device
Lyphochek® Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals.
The control is provided in lyophilized form for increased stability
06_510(k) Itm_580 05/01
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Statement of Intended Use 5.0
Lyphochek® Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.
Comparison of the new device with the Predicate Device 6.0
The new Lyphochek® Tumor Marker Control claims substantial equivalence to the Lyphochek® Tumor Marker Control currently in commercial distribution (K992172). The new Lyphochek® Tumor Marker Control has improved open-vial stability claims for CA 27-29, and improved reconstituted freeze-thaw stability claims for PSA, Calcitonin, and ACTH.
| Bio Rad | Bio Rad | |
|---|---|---|
| Characteristics | Lyphochek® Tumor Marker Control | Lyphochek® Tumor Marker Control |
| (New Device) | (Predicate Device) | |
| Similarities | ||
| Intended Use | The Lyphochek® Tumor MarkerControl is intended for use as anassayed quality control serum tomonitor the precision of laboratorytesting procedures for theanalytes listed in the packageinsert. | The Lyphochek® Tumor MarkerControl is intended for use as anassayed quality control serum tomonitor the precision of laboratorytesting procedures for the analyteslisted in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum based | Human serum based |
| Storage(Unopened) | 2°C to 8°Cuntil expiration date | 2°C to 8°Cuntil expiration date |
| Differences | ||
| OpenVial Claim | All analytes will be stable for 14days when stored at 2 - 8°C withthe following exceptions: Ferritinand CA 27-29 will be stable for 6days. ACTH, Free PSA, PSA, andCalcitonin should be assayedimmediately followingreconstitution. | All analytes will be stable for 14days when stored at 2 - 8°C withthe following exceptions: ACTH,Free PSA, PSA, and Calcitoninshould be assayed immediatelyfollowing reconstitution. |
| ReconstitutedFreeze VialClaim | All analytes will be stable afterreconstituting and freezing for 30days when stored at -10°C to -20°C. | All analytes will be stable for 30days after reconstituting andfreezing when stored at -10°C to -20 °C, with the followingexceptions: (1) PSA will be stablefor 20 days and (2) ACTH and |
Table 1. Similarities and Differences between new and predicate device.
06_510(k) ltm 580 05/01
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| Calcitonin do not have frozen |
|---|
| stability claims.Company of the comments of the first for the commend of the Research and AMER Management of AMERICAN Company of CARRANT Program |
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Tumor Marker Control. Product claims are as follows:
- 7.1 Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 - 8°C, with the following exceptions: Ferritin and CA 27-29 will be stable for 6 days. ACTH, Free PSA, PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. For optimum precision of Ferritin, allow vial to equilibrate for a minimum of 2 hours prior to assay.
- 7.2 After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10℃ to -20 ℃. Once thawed, do not refreeze the control; discard remaining material.
- 7.3 The control is stable for 3 years and 3 months when stored unopened at 2 - 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name arranged in a circular pattern around a central emblem. The emblem is a stylized representation of an eagle, with three curved lines forming its body and wings.
JUN 2 6 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboraties, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
510(K) Number: K011579 Re: Trade/Device Name: Lyphochek® Tumor Marker Control Regulation Number: 862.1660 Regulatory Class: I Product Code: JJY Dated: May 18, 2001 Received: May 22, 2001
Dear Ms. Chapman:
We have reviewed your Section 510(k) notification of intent to market the device referenced with have loviewed your betermined the device is substantially equivalent (for the indications for use atoo in the enclosure) to legally marketed predicate devices marketed in interstate commerce sured in and 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provision associated in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Oostions of the Act. The general controls provisions of the Act include requirements for annual profistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K011579 510 (k) Number (if known):_
Device Name: Lyphochek® Tumor Marker Control
Indications for Use:
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.
Signature
(Division Sign-Off) Division of Clinical Laboratory Devices K011579 510(k) Number _
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
or
Over-the Counter use
§ 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.