(46 days)
K8a2a02
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No
The document describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as a quality control material used to monitor the precision of laboratory testing procedures, not to treat or diagnose a disease.
No
Explanation: The device is a quality control material used to monitor the precision of laboratory testing procedures, not to diagnose a disease or condition in a patient.
No
The device description explicitly states it is prepared from human whole blood and provided in lyophilized form, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This is a classic function of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description states it's "prepared from human whole blood with added pure chemicals." This confirms it's a material derived from a human specimen used in a laboratory setting.
- Intended User / Care Setting: The intended user is "laboratory testing procedures," which is where IVDs are used.
While the document doesn't explicitly use the term "IVD," the intended use, device description, and intended user/care setting all align perfectly with the definition of an In Vitro Diagnostic device. It's a control material used in vitro (outside the body) to assess the performance of diagnostic tests.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
Lyphochek Whole Blood Control is prepared from human whole blood with added pure chemicals. The control is provided in lyophilized form for increased stability.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K8a2a02
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/3 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in a bold, sans-serif font.
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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Image /page/1/Picture/3 description: The image shows the logo for Bio-Rad. The logo is in white text on a black background. The text is in a bold, sans-serif font and is enclosed in a rounded rectangle.
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 Blood
Control | Lyphochek Whole Blood
Control
(new submission) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | An assayed quality control
material to monitor the
precision of laboratory
testing procedures for the
analytes listed in the
package insert. | An assayed quality control
material to monitor the
precision of laboratory
testing procedures for the
analytes listed in the
package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Whole Blood | Whole Blood |
| Storage | 2-8°C | 2-8°C |
| Analytes | Cyclosporine, Lead, Red
Cell Folate | Cyclosporine, FK-506, Lead,
Red Cell Folate |
| Open Vial
Claim | 14 days when stored tightly
capped at 2-8°C with the
following exception: (1) red
cell folate will be stable for 3
days. | 14 days when stored tightly
capped at 2-8°C with the
following exception: (1) red
cell folate will be stable for 3
days. |
| Differences | Previous product did not
contain FK-506 | Contains FK-506 |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
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 | ✓ |
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------------------ | ----------------------------- |
OR
Over-The Counter Use | |
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---------------------- | -- |
(Division Sign-Off) | |
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Division of Clinical Laboratory Devices |
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510(k) Number | K980871 |
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--------------- | --------- |