(56 days)
An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.
Here's an analysis of the provided text regarding the Lyphochek® Whole Blood Metals Control, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA submission for the Lyphochek® Whole Blood Metals Control focuses on demonstrating substantial equivalence to a predicate device and establishing stability claims, rather than defining and directly reporting against specific numerical "acceptance criteria" in the way one might see for diagnostic accuracy. The key performance indicators are related to the stability of the control material.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Opened Vial Stability (2-8°C) | All analytes stable for 14 days, with the exception of red cell folate, which is stable for 1 day. |
| Unopened Vial Shelf Life (2-8°C) | Stable for 3 years and 3 months. |
| Substantial Equivalence to Predicate Device (K984477) | The new device shares the same intended use, lyophilized form, human whole blood matrix, and unopened storage conditions as the predicate. The differences (expanded analyte list, shorter red cell folate opened stability) do not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of number of patient samples or production lots. The stability studies likely involved multiple vials/lots of the control material. For the substantial equivalence argument, the comparison is qualitative between the new and predicate device specifications rather than a quantitative test of a specific dataset.
- Data Provenance: The data comes from internal "stability studies" performed by Bio-Rad Laboratories. The information provided does not specify the country of origin for the data or whether it was retrospective or prospective. Given that it's a stability study for a new product, it would inherently be prospective in nature, testing the product over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device. The Lyphochek® Whole Blood Metals Control is a quality control material, not a diagnostic device that requires expert interpretation of results to establish ground truth. Its performance is assessed through analytical stability testing using established laboratory methods for measuring the target analytes.
4. Adjudication Method for the Test Set
This is not applicable. There is no "adjudication method" in the context of stability testing for a quality control material. The performance is determined by instrument measurements against specified analytical criteria over time.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This device is a quality control material, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is a physical control material, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies would be the expected analytical values for each analyte within the control material, determined by reference methods or manufacturing specifications. The stability is then assessed by measuring the analytes over time and comparing the results to these established reference values, ensuring they remain within acceptable limits. This is an analytical ground truth, not a clinical ground truth derived from pathology or patient outcomes.
8. The Sample Size for the Training Set
This is not applicable. This device is a quality control material and does not involve machine learning or a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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APR 2 2 2002
Summary of Safety and Effectiveness Lyphochek® Whole Blood Metals Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
February 21, 2002
2.0 Device Identification
Lyphochek® Whole Blood Metals Control Product Trade Name: Multi-Analyte Controls, (Assayed and unassayed) Common Name: Class I Classifications:
75JJY Product Code: CFR 862.1660 Requlation Number:
Device to Which Substantial Equivalence is Claimed 3.0
Lyphochek® Whole Blood Metals Control Bio-Rad Laboratories
510 (k) Number: K984477
Description of Device 4.0
The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.
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5.0 Statement of Intended Use
The new Lyphochek® Whole Blood Metals Control is an assayed control used for monitoring 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
This control is substantially equivalent to the following quality control material for whole blood metals analysis that is currently in the market:
Lyphochek® Whole Blood Metals Control Bio-Rad Laboratories
510 (k) Number: K984477
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Lyphochek® Whole BloodMetals Control(New Device) | Lyphochek® Whole Blood MetalsControl(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Lyphochek® Whole Blood MetalsControl is intended for use as aassayed quality control to monitorthe precision of laboratory testingprocedures for the analytes listedin the package insert. | Lyphochek® Whole Blood MetalsControl is intended for use as aassayed quality control to monitorthe precision of laboratory testingprocedures for the analytes listedin the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Whole Blood | Human Whole Blood |
| Storage(Unopened) | 2°C to 8°Cuntil expiration date | 2°C to 8°Cuntil expiration date |
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| Differences | ||
|---|---|---|
| Analyte listing | The Lyphochek® Whole BloodMetals Control may be used totest for:Arsenic Cadmium Mercury Thallium Red Cell Folate Lead | The Lyphochek® Whole BloodMetals Control may be used to testfor:Red Cell Folate Lead |
| Storage(Opened) | Once opened all analytes will bestable for 14 days with thefollowing exception: red cell folatewill be stable for 1 day. | Once opened all analytes will bestable for 14 days with thefollowing exception: red cell folatewill be stable for 3 days.[No claims for Arsenic, Cadmium,Mercury, and Thallium]. |
Summary of Performance Data 7.0
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Whole Blood Metals Control. Product claims are as follows:
- 7.1 Once the control is reconstituted, all analytes will be stable for 14 days when stored at 2-8°C with the following exception: red cell folate will be stable for 1 day.
- The control is stable for 3 years and 3 months when stored unopened at 7.2 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the staff and a snake winding around it.
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APR 2 2 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K020610
Trade/Device Name: Lyphochek® Whole Blood Metals Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I reserved Product Code: DIE Dated: February 21, 2002 Received: February 25, 2002
Dear Ms. Lloyd:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis lower will and it your ding of substantial equivalence of your device to a legally marketed predication. THE I Dir 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 1 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, (201) 591 1500: Tradition 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 miorination on your respons and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.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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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Lyphochek® Whole Blood Metals Control Device Name:
Indications for Use:
An assayed quality control serum to monitor the precision of laboratory An assuyou quality for analytes listed in the package insert.
Tom Coon
vision of Clinical Laboratory Devices 0911410 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
§ 862.3280 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.