(66 days)
Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the 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 Lyphochek Tumor Marker Control device, focusing on the requested criteria.
Note: The provided document is a 510(k) summary for a diagnostic control product. This type of device does not typically involve the same kind of "performance studies" (e.g., clinical trials, AI algorithm evaluations) as medical imaging devices or treatment devices. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable in this context and cannot be answered from the provided text. The "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device for safety and effectiveness, primarily through comparing technological characteristics and intended use.
Acceptance Criteria and Device Performance for Lyphochek Tumor Marker Control
1. Table of Acceptance Criteria and Reported Device Performance
For diagnostic control products like the Lyphochek Tumor Marker Control, "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence to an existing legally marketed predicate device (K983807 in this case). The primary "performance" is the ability to monitor the precision of laboratory testing procedures, which is established by having comparable characteristics and intended use to the predicate. The provided document focuses on these comparative characteristics rather than specific quantitative performance metrics as might be found for a new diagnostic assay.
| Characteristic | Acceptance Criteria (Compared to Predicate Device K983807) | Reported Device Performance (New Device: Lyphochek Tumor Marker Control) |
|---|---|---|
| Intended Use | Must be an assayed quality control serum to monitor the precision of laboratory testing procedures for listed analytes, identical to the predicate. | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (Identical to predicate) |
| Form | Lyophilized, identical to the predicate. | Lyophilized (Identical to predicate) |
| Matrix | Human serum, identical to the predicate. | Human serum (Identical to predicate) |
| Storage | 2-8°C, identical to the predicate. | 2-8°C (Identical to predicate) |
| Open Vial Claim | • 14 days when stored tightly capped at 2-8°C (with exceptions for ACTH, Free PSA, PSA, Calcitonin to be assayed immediately).• 30 days after reconstituting and freezing at -10°C to -20°C (with exceptions for PSA (20 days) and ACTH/Calcitonin (no frozen stability claims)). Must be identical to the predicate. | • 14 days when stored tightly capped at 2-8°C, with the following exceptions: ACTH, Free PSA, PSA and Calcitonin should be assayed immediately following reconstitution.• 30 days after reconstituting and freezing at -10°C to -20°C with the following exceptions: (1) PSA will be stable for 20 days when stored frozen at -10°C to -20°C and (2) ACTH and Calcitonin do not have frozen stability claims. (Identical to predicate) |
| Differences | Must not introduce new questions of safety or effectiveness. Any differences should be supported by data or demonstrate equivalency. The new device has additional analytes. | Claims for additional analytes: CA 50, CA 195, CA 549, and CASA. The implication is that the performance for these additional analytes is also acceptable as a quality control. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. For a diagnostic control, the "test set" would typically refer to the data generated during validation studies to establish the stability and consistency of the control across various analytical platforms for the listed analytes. This would usually involve internal laboratory testing. The document states it is "prepared from human serum," implying human-derived components.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable for this type of device and is therefore not provided in the 510(k) summary. For a diagnostic control, "ground truth" is established by the assigned target values and ranges for each analyte, typically determined through extensive analytical testing using reference methods and statistical analysis in a laboratory setting.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and is therefore not provided in the 510(k) summary. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not the focus of a diagnostic control device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is typically for evaluating the impact of a diagnostic imaging device or algorithm on human reader performance, which is not relevant for a quality control product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
No, a standalone performance study in the context of an "algorithm" was not done. This device is a physical control material, not a software algorithm. Its "performance" relates to its inherent stability and the accuracy/precision of its assigned values when used in laboratory instruments.
7. The Type of Ground Truth Used
The "ground truth" for a diagnostic control product like the Lyphochek Tumor Marker Control is the assigned target values and acceptable ranges for each analyte, determined through analytical methods and statistical evaluation rather than expert consensus on a clinical case or pathology findings. The summary implies these assigned values are derived from rigorous laboratory testing.
8. The Sample Size for the Training Set
This information is not applicable for this type of device in the context of machine learning or AI, and therefore not provided. The "training" for a diagnostic control involves the analytical characterization and value assignment processes in the laboratory, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" for an AI algorithm is not applicable here. The "ground truth" (assigned values/ranges) for the control material would be established through a robust process of repeated analytical testing across multiple instruments and laboratories, using reference methods, and subjected to statistical analysis to determine the mean and standard deviation for each analyte. This process ensures the control reliably reflects known concentrations.
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SEP - 2 1999
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aboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation June 25, 1999
Device (Trade & Common Name) Lyphochek Tumor Marker Control
Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Control, All Kinds (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California K983807
Statement of Intended Use
Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the 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.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Tumor Marker Control and the devices to which substantial equivalence is claimed.
| Bio-Rad Lyphochek Tumor MarkerControl (New Device) | Bio-Rad Lyphochek Tumor MarkerControl (Substantially EquivalentDevice) | |
|---|---|---|
| IntendedUse | An assayed quality control serum tomonitor the precision of laboratorytesting procedures for the analyteslisted in the package insert. | An assayed quality control serum tomonitor the precision of laboratorytesting procedures for the analyteslisted in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Open VialClaim | • 14 days when stored tightlycapped at 2-8°C, with the followingexceptions: ACTH, Free PSA, PSAand Calcitonin should be assayedimmediately followingreconstitution.• 30 days after reconstituting andfreezing at -10°C to -20°C with thefollowing exceptions: (1) PSA willbe stable for 20 days when storedfrozen at -10°C to -20°C and (2)ACTH and Calcitonin do not havefrozen stability claims. | • 14 days when stored tightlycapped at 2-8°C, with the followingexceptions: ACTH, Free PSA, PSAand Calcitonin should be assayedimmediately followingreconstitution.• 30 days after reconstituting andfreezing at -10°C to -20°C with thefollowing exceptions: (1) PSA willbe stable for 20 days when storedfrozen at -10°C to -20°C and (2)ACTH and Calcitonin do not havefrozen stability claims. |
| Differences | Same analytes as the substantiallyequivalent device and additionalclaims for the following : CA 50,CA 195, CA 549 and CASA. | Refer to attached substantiallyequivalent device product insert. |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP -2 1999
Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
K992172 Trade Name: Lyphochek Tumor Marker Control Regulatory Class: I Product Code: JJY Dated: June 25, 1999 Received: June 28, 1999
Dear Ms. Platt:
Re:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 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/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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Page 1 of 1
510(k) Number: ______________________________________________________________________________________________________________________________________________________________ Device Name: Lyphochek Tumor Marker Control
Indications for Use:
Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992172 |
Prescription Use
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2
1994
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.