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: Sirolimus, Tacrolimus, Cyclosporine. 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.

Device Description

Lyphochek Whole Blood Immunosuppressant Controls and Abbott Immunosuppressant MCC are both prepared from human whole blood, with added chemicals, and stabilizers.

AI/ML Overview

This appears to be a 510(k) premarket notification for in-vitro diagnostic control materials, not a device that involves AI or requires the detailed study information you've requested. The provided text describes the product, its intended use, a comparison to a predicate device, and stability studies. It does not mention any AI algorithms, deep learning, imaging analysis, or human-in-the-loop performance studies that would necessitate the fields you've outlined.

Therefore, many of the requested fields cannot be filled from the provided document. I can, however, provide the acceptance criteria and the type of study mentioned for this specific device.

Acceptance Criteria and Device Performance (Based on provided text)

Acceptance Criteria (Implied)	Reported Device Performance
Open vial stability for all analytes at 2-8°C	14 days
Open vial stability for all analytes at -20 to -70°C	30 days
Shelf life at 2 to 8°C	3 Years
Substantial equivalence to predicate device for intended use	Claimed and accepted by FDA (K072721 vs. K022041)
Monitor the precision of laboratory testing procedures	Intended use; performance demonstrated via stability studies

Information that Cannot Be Extracted from the Provided Document (and why):

This document describes a quality control material used to monitor the precision of laboratory tests, not a diagnostic device that analyzes data or images and thus would not involve the following:

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples used in stability studies, not patient data for algorithm evaluation. The document states "All supporting data is retained on file at Bio-Rad Laboratories" but does not provide specific sample sizes or provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/imaging device would refer to clinical diagnoses or expert annotations. For a control material, "ground truth" would be the known concentration of analytes, established through analytical methods, not expert consensus.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a control material, not an AI-powered diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a control material, the "ground truth" would be the certified values/concentrations of the analytes within the control, established by chemical analysis and reference methods, not expert consensus or pathology on patient data.
The sample size for the training set: Not applicable. There is no AI model or training set.
How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's performance against its acceptance criteria is demonstrated through stability studies. These studies aim to prove that the control material maintains its integrity and expected analyte concentrations over time under specified storage conditions (shelf-life and open-vial stability). The document states:

"Stability studies have been performed to determine the open vial stability and shelf life for this control."
"Product claims are as follows: 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."

The FDA's acceptance of the 510(k) (K072721) indicates that these stability studies and the comparison to the predicate device (K022041) were deemed sufficient to prove substantial equivalence and meet regulatory requirements for a Class I clinical toxicology control material.

Summary

{0}------------------------------------------------

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 materialsClinical 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-RadLyphochek Whole Blood Immunosuppressant ControlsAbbott Immunosuppressant MCC(New Device)	Bio-RadLyphochek Whole Blood Control(Predicate Device K022041)
Similarities
Intended Use	Lyphochek Whole Blood Immunosuppressant Control or AbbottImmunosuppressant-MCC is intended for use as an assayedquality control serum to monitor the precision of laboratory testingprocedures for the analytes listed in the package insert.	Lyphochek Whole Blood Control isintended for use as an assayed qualitycontrol serum to monitor the precisionof laboratory testing procedures for theanalytes listed in the package insert.
Form	Lyophilized	Lyophilized
Storage (Unopened)	2-8°C until expiration date	2-8°C until expiration date
Open vial afterReconstitution(Refrigerated)	14 days at 2 to 8°C.	14 days at 2 to 8°C with the followingexceptions: Red cell folate will be stablefor 3 days at 2 to 8°C.
Open vial afterReconstitution(Frozen)	30 days at -20 to -70°C.	30 days at -10 to -20°C.
Differences
Matrix	EDTA Whole blood	Citrated Whole blood
Analytes	CyclosporineSirolimusTacrolimus	CyclosporineSirolimusTacrolimusRed CellFolateLeadSerotonin

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.

{2}------------------------------------------------

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).

{3}------------------------------------------------

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

{4}------------------------------------------------

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
--------	---------

Page 1 of	1
-----------	---

Regulation Number and Section

§ 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.