(22 days)
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.
Lyphochek® Whole Blood Control is prepared from human whole blood, with pure chemicals, and stabilizers added. The control is provided in lyophilized form for increased stability.
The provided text is a Premarket Notification (510(k)) for the Lyphochek® Whole Blood Control, which is a quality control material used for laboratory analytes. This type of device is not an AI/ML device and therefore the questions regarding acceptance criteria and studies that prove the device meets acceptance criteria in the context of AI/ML are not directly applicable.
The document focuses on demonstrating substantial equivalence to a previously marketed predicate device (K980871) by showing similar intended use, form, and matrix, while highlighting the addition of a new analyte (Sirolimus).
However, I can extract the information related to the device's performance based on the type of product it is (a quality control material).
Description of Device and Basis for Approval
The Lyphochek® Whole Blood Control is a lyophilized human whole blood-based control material intended to monitor the precision of laboratory tests for various analytes. The 510(k) submission seeks to establish substantial equivalence to a previously cleared device (K980871), with the primary difference being the inclusion of Sirolimus as an additional analyte.
The approval is based on demonstrating that the new device has the same intended use, fundamental technology (lyophilized human whole blood matrix), and comparable performance (stability) to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material like Lyphochek® Whole Blood Control, 'acceptance criteria' typically relate to its stability and ability to maintain the target values for analytes over time.
| Characteristic | Acceptance Criteria (Performance Claim) | Reported Device Performance (Summary of Performance Data) |
|---|---|---|
| Reconstituted Stability | All analytes stable for 14 days at 2°C to 8°C. Exception: Red Cell Folate stable for 3 days at 2°C to 8°C. | "Once the control material is reconstituted, all analytes will be stable for 14 days at 2℃ to 8 ℃ with the following the exception: Red Cell Folate will be stable for 3 days at 2°C to 8°C." This directly matches the claim/criterion. |
| Shelf Life (Unopened) | Three years and three months when stored at 2°C to 8°C. | "Three years and three months when stored at 2 to 8 °C." This directly matches the claim/criterion. "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." This indicates a commitment to ongoing validation. |
| Frozen Stability (after reconstitution) | All analytes stable for 30 days when stored tightly capped at -10°C to -20°C. | The table of similarities and differences states: "After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10 to -20°C." This matches the claim/criterion. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Whole Blood Control." It also mentions, "All supporting data is retained on file at Bio-Rad Laboratories."
- Sample size for the test set: Not explicitly stated in the provided summary. However, for real-time stability studies of a diagnostic reagent, a statistically significant number of vials/lots would be tested over time.
- Data provenance: Not explicitly stated, but as Bio-Rad Laboratories is a US-based company, it is likely tested in the US. The studies are prospective in nature, as they involve monitoring the product over time to establish stability claims.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This question is not applicable. The device is a quality control material, not a diagnostic device that requires expert interpretation for a "test set ground truth." The "ground truth" for a control material is its chemical composition and stability, which is determined through analytical reference methods and validated manufacturing processes, rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This question is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1) are for interpreting complex clinical data, not for verifying the stability of a chemical reagent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This question is not applicable. An MRMC study is designed to evaluate the effectiveness of an AI system, often in imaging, by comparing human reader performance with and without AI assistance across multiple cases and readers. The Lyphochek® Whole Blood Control is a laboratory reagent, not an AI/ML diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
This question is not applicable, as the device is not an algorithm or AI/ML system.
7. The Type of Ground Truth Used
The "ground truth" for a quality control material like this would be established through:
- Quantitative analytical methods: Using highly accurate and precise analytical instruments and reference methods to precisely determine the concentration of each analyte within the control material at different time points and under different storage conditions.
- Reference material traceability: Ensuring the values are traceable to international or national reference materials where available.
- Manufacturing specifications: The material is manufactured to specific chemical formulations, and its performance is assessed against these established specifications.
8. The Sample Size for the Training Set
This question is not applicable. The device is not an AI/ML system, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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102204/
JUL 1 6 2002 Bio-Rad Laboratories Premarket Notification Section 510(k) for Lyphochek Whole Blood Control Summary of Safety and Effectiveness
Page 1 of 2
Summary of Safety and Effectiveness Lyphochek® Whole Blood Control
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
Contact Person
Maria Zeballos Regulatory Affairs Specialist (949) 598-1367 Telephone:
Date of Summary Preparation
June 18, 2002
2.0 Device Identification
| Product Trade Name: | Lyphochek® Whole Blood Control |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Lyphochek® Whole Blood Control Bio-Rad Laboratories Irvine, California
Docket Number: K980871
4.0 Description of Device
Lyphochek® Whole Blood Control is prepared from human whole blood, with pure chemicals, and stabilizers added. The control is provided in lyophilized form for increased stability.
5.0 Statement of Intended Use
Lyphochek® Whole Blood Control are intended for use as an assayed quality control material to monitor the precision of laboratory analytes listed in the package insert.
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6.0 Comparison of the new device with the Predicate Device
Lyphochek® Whole Blood Control claims substantial equivalence to the Lyphochek® Whole Blood Control currently in commercial distribution (K980871). The new Lyphochek® Whole Blood Control contains Sirolimus and the current product does not.
| Characteristics | Bio RadLyphochek® Whole Blood Control(New Device) | Bio RadLyphochek® Whole Blood Control(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | Lyphochek® Whole Blood Control is intended foruse as an assayed quality control material tomonitor the precision of laboratory testingprocedures for the analytes listed in the packageinsert. | Lyphochek® Whole Blood Control is intended foruse as an assayed quality control material tomonitor the precision of laboratory testingprocedures for the analytes listed in the packageinsert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Processed Human Whole Blood Lysate | Processed Human Whole Blood Lysate |
| Differences | ||
| Storage(Unopened) | 2-8°Cuntil expiration date | 2-8°Cuntil expiration date |
| ReconstitutedVial Claim | 14 days at 2°C to 8 °CException: Red cell folate will be stable for 3days at 2°C to 8°C. | 14 days at 2°C to 8 °CException: Red cell folate will be stable for 3 daysat 2°C to 8°C. |
| Afterreconstitutingand freezing | After reconstituting and freezing the control, allanalytes will be stable for 30 days when storedtightly capped at -10 to -20°C. | After reconstituting and freezing the control, allanalytes will be stable for 30 days when storedtightly capped at -10 to -20°C. |
| Analytes | Contains: Cyclosporine, Lead, Red Cell Folate,Tacrolimus and Sirolimus. | Contains: Cyclosporine, Lead, Red Cell Folate,TacrolimusDoes not Contain: Sirolimus |
Table 1, Similarities and Differences hetween new and predicate device
7.0 Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Lyphochek® Whole Blood Control. Product claims are as follows:
- 7.1 Reconstituted Stability: Once the control material is reconstituted, all analytes will be stable for 14 days at 2℃ to 8 ℃ with the following the exception: Red Cell Folate will be stable for 3 days at 2°C to 8°C.
- 7.2 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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Food and Drug Administration 2098 Gaither Road ي ينهنجي ويوري ويورووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووووو Rockville MD 20850
リリー 1 6 2002
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618
Re: K022041 Trade/Device Name: Lyphochek® Whole Blood Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 18, 2002 Received: June 24, 2002
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 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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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 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, 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 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/odrb/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 Control Device Name: Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Over-the Counter use_
Olan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. KO22041
§ 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.