(76 days)
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No
The document describes quality control materials for laboratory testing and does not mention any AI or ML components in its intended use, device description, or performance studies.
No
The device is described as an assayed quality control material used to monitor the precision of laboratory testing procedures, not to treat or diagnose a medical condition.
No
Explanation: This device is described as a quality control material used to monitor the precision of laboratory testing procedures, not to diagnose medical conditions in patients. It helps ensure the accuracy of assays for immunosuppressant drugs but does not provide diagnostic information about a patient's health.
No
The device description explicitly states that the controls are prepared from human whole blood with added chemicals and stabilizers, indicating a physical, non-software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it 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." This clearly indicates it is used in vitro (outside the body) to assess the performance of laboratory tests.
- Device Description: The description mentions it is "prepared from human whole blood, with added chemicals, and stabilizers." This is consistent with the composition of materials used in in vitro diagnostic testing.
- Intended User / Care Setting: The intended user is described as being involved in "laboratory testing procedures," which is the typical setting for IVD use.
- Predicate Device: The mention of a predicate device (K022041; Lyphochek Whole Blood Control) further supports its classification as an IVD, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
While the document doesn't mention image processing, AI, or specific performance metrics like sensitivity or specificity (which are more relevant for diagnostic tests themselves, not controls), the core function and description align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lyphochek Whole Blood Immunosuppressant Controls or Abbott Immunosuppressant MCC 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.
The following analytes are listed in the package insert:
- Sirolimus
- Tacrolimus
- Cyclosporine
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.
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
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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)
Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:
- Open vial Stability:
- After reconstituting, all analytes will be stable for 14 days at 2 to 8°C or 30 days at -20 to -70°C.
- Shelf Life: 3 Years at 2 to 8°C
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.
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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Bio-Rad Laboratories Whole Blood Immunosuppressant Controls Summary of Safety and Effectiveness
KO7272|
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
DEC 1 1 2007
Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467
Date of Summary Preparation
September 13, 2007
2.0 Device Identification
| Product Name: | - Lyphochek Whole Blood Immunosuppressant Control
- Abbott Immunosuppressant MCC |
|---------------|-------------------------------------------------------------------------------------|
| Common Name: | Drug mixture control materials
Clinical toxicology control material. |
Classification: Product Code: Regulation Number:
Class I DIF 21 CFR 862.3280
3.0 Device to Which Substantial Equivalence is Claimed
Lyphochek Whole Blood Control Bio-Rad Laboratories Irvine, California 92618
510 (k) Number: K022041
4.0 Description of Device
Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.
1
5.0 Intended Use
Lyphochek Whole Blood Immunosuppressant Controls or Abbott Immunosuppressant MCC 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.
1.0 Comparison of the new device with the Predicate Device
Whole Blood Immunosuppressant Controls claim substantial equivalence to the Lyphochek Whole Blood Control currently in commercial distribution (K022041).
| Characteristics | Bio-Rad
Lyphochek Whole Blood Immunosuppressant Controls
Abbott Immunosuppressant MCC
(New Device) | Bio-Rad
Lyphochek Whole Blood Control
(Predicate Device K022041) |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek Whole Blood Immunosuppressant Control or Abbott
Immunosuppressant-MCC 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 Whole Blood 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. |
| Form | Lyophilized | Lyophilized |
| Storage (Unopened) | 2-8°C until expiration date | 2-8°C until expiration date |
| Open vial after
Reconstitution
(Refrigerated) | 14 days at 2 to 8°C. | 14 days at 2 to 8°C with the following
exceptions: Red cell folate will be stable
for 3 days at 2 to 8°C. |
| Open vial after
Reconstitution
(Frozen) | 30 days at -20 to -70°C. | 30 days at -10 to -20°C. |
| Differences | | |
| Matrix | EDTA Whole blood | Citrated Whole blood |
| Analytes | Cyclosporine
Sirolimus
Tacrolimus | Cyclosporine
Sirolimus
Tacrolimus
Red Cell
Folate
Lead
Serotonin |
Table 1: Similarities and Differences between new and predicate device
6.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:
- . Open vial Stability:
- ▶ After reconstituting, all analytes will be stable for 14 days at 2 to 8°C or 30 days at -20 to -70°C.
- . Shelf Life: 3 Years at 2 to 8°C
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is encircled by the words "U.S. Department of Health and Human Services" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
BioRad Laboratories Inc. Diagnostics Group c/o Ms. Elizabeth Platt 9500 Jeronimo Road Irvine, CA 92618-2017
DEC 1 1 2007
K072721 Re:
Trade/Device Name: Lyphochek Whole Blood Immunosuppressant Control Regulation Number: 21 CFR§862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: Class I, reserved Product Code: DIF Dated: September 21, 2007 Received: September 26, 2007
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1 ogally marketed predicate device results in a classification for your device on thus, perroits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the &ct from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K072721 |
|---|---|
| Device Name: | Lyphochek Whole Blood Immunosuppressant Control |
| Indications For Use: | Lyphochek Whole Blood Immunosuppressant Controls 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. |
| The following analytes are listed in the package insert: | |
| SirolimusTacrolimusCyclosporine | |
| Device Name: | Abbott Immunosuppressant MCC |
Indications For Use:
Abbott Immunosuppressant MCC 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.
The following analytes are listed in the package insert:
- Sirolimus ▲
- Tacrolimus ▶
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
| Division Sign-Off | |
|---|---|
| ------------------- | -- |
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K072721 |
|---|---|
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