(46 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 this package insert.
Lyphochek Whole Blood Control is prepared from human whole blood with added pure chemicals. The control is provided in lyophilized form for increased stability.
This document is a 510(k) summary for the Lyphochek Whole Blood Control. It describes the device, its intended use, and claims substantial equivalence to an existing device. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study data, or ground truth establishment.
Therefore, I cannot provide a table of acceptance criteria or details about a study that proves the device meets specific performance standards based on the provided text. The document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to an older product, not on presenting detailed performance study data against defined acceptance criteria.
The information that is available in the document, which might be tangentially related but does not fully answer the prompt, includes:
- Device Performance (Implicit): The device is intended "to monitor the precision of laboratory testing procedures" for analytes like Cyclosporine, Lead, and Red Cell Folate. Its performance is implied to be similar to its predicate device.
- Sample Size/Data Provenance: Not mentioned for any test set to prove acceptance criteria.
- Experts/Ground Truth: Not mentioned in the context of establishing acceptance criteria or study outcomes.
- Adjudication Method: Not applicable as no study with expert review is described.
- MRMC Study: Not applicable.
- Standalone Performance: Not applicable in the context of what's described.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size/Ground Truth: Not applicable as this is not an AI/algorithm-based device requiring training.
The document is a regulatory submission for a quality control material, not a data-driven performance study report for an AI or diagnostic device with explicit acceptance criteria.
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aboratories
Diagnostics Group 9500 Jeronimo Road Invine, California 92618-2017 Telephone: (714) 598-1200
KA80871
510(k) Summary
APR - 6 1998
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (714)598-1285 Fax (714)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation March 24, 1998
Device (Trade & Common Name) Lyphochek Whole Blood Control
Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed
Lyphochek Whole Blood Control Bio-Rad Laboratories, Irvine, CA K8a2a02
Statement of Intended 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 this package Insert.
Description of the Device
Lyphochek Whole Blood Control is prepared from human whole blood with added pure chemicals. The control is provided in iyophilized form for increased stability.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
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Blo-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
A table is provided below comparing the similarities between the Bio-Rad Lyphochek Whole Blood Control and the device to which substantial equivalence is claimed.
| Lyphochek Whole BloodControl | Lyphochek Whole BloodControl(new submission) | |
|---|---|---|
| IntendedUse | An assayed quality controlmaterial to monitor theprecision of laboratorytesting procedures for theanalytes listed in thepackage insert. | An assayed quality controlmaterial to monitor theprecision of laboratorytesting procedures for theanalytes listed in thepackage insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Whole Blood | Whole Blood |
| Storage | 2-8°C | 2-8°C |
| Analytes | Cyclosporine, Lead, RedCell Folate | Cyclosporine, FK-506, Lead,Red Cell Folate |
| Open VialClaim | 14 days when stored tightlycapped at 2-8°C with thefollowing exception: (1) redcell folate will be stable for 3days. | 14 days when stored tightlycapped at 2-8°C with thefollowing exception: (1) redcell folate will be stable for 3days. |
| Differences | Previous product did notcontain FK-506 | Contains FK-506 |
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Food and Drug Administration 2098 Gaither Road APR = 6 1908 Rockville MD 20850
Elizabeth Platt Acting Requlatory Affairs/Quality Assurance Manager Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re : K980871 Lyphochek Whole Blood Control Requlatory Class: I & III Product Code: DIF Dated: March 24, 1998 Received: March 27, 1998
Dear Ms. Platt:
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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 setmas as 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 In addition, FDA may publish further announcements action. 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/dsmamain.html".
Sincerely yours,
Steven Litman
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:
Device Name: Lyphochek Whole Blood Control
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 this package insert.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| Prescription Use | ✓ |
|---|---|
| ------------------ | ----------------------------- |
OR
| Over-The Counter Use | |
|---|---|
| ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices |
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| 510(k) Number | K980871 |
|---|---|
| --------------- | --------- |
§ 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.