The Emit® 2000 Tacrolimus Assay is for in vitro quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients.

The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.

Device Description

The Emit® 2000 Tacrolimus Assay is for in vitro diagnostic use for the quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients. The Emit® 2000 Tacrolimus Assay is comprised of an antibody reagent, a buffer reagent and an enzyme reagent. This assay contains mouse monoclonal antibodies with a high specificity for tacrolimus.

The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay. The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Tacrolimus Assay. The pretreatment process lyses the cells, extracts the tacrolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing tacrolimus is then assayed using the Emit® 2000 Tacrolimus Assay.

AI/ML Overview

The provided document K060385 describes the Emit® 2000 Tacrolimus Assay and its associated Sample Pretreatment Reagent. The study presented compares the performance of this new assay against two established methods: Liquid Chromatography/Mass Spectrometry (LC/MS) and the Abbott IMx® Tacrolimus II Assay.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., a specific minimum slope and correlation coefficient). Instead, it presents the results of method comparison studies and implies that these results demonstrate substantial equivalence to the predicate devices. The "reported device performance" refers to the results obtained from these comparison studies.

Comparative Method	Reported Performance Metric	Value (All samples)
LC/MS/MS	Slope	1.15
	Intercept	-0.33
	R-value (Correlation)	0.940
Abbott IMx® Tacrolimus II	Slope	0.92
	Intercept	-0.04
	R-value (Correlation)	0.881

Note: Since explicit acceptance criteria are not provided, the "acceptance criteria" column is implicitly an expectation of strong correlation and a slope/intercept close to 1 and 0 respectively for substantial equivalence, which the reported performance aims to demonstrate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- For comparison against LC/MS/MS: 197 samples (All samples)
- For comparison against Abbott IMx® Tacrolimus II Assay: 192 samples (All samples)
Data Provenance: The samples were from "2 transplant groups (liver and kidney)". The studies were "conducted at two external sites". This indicates the data is prospective or at least gathered specifically for this study, and likely from a clinical setting. The country of origin is not explicitly stated, but given the manufacturer (Dade Behring Inc., US-based) and the FDA submission, it is likely the data was collected in the United States.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For methods like LC/MS/MS, the "ground truth" is typically defined by the analytical method itself rather than human expert interpretation of results, as it is considered a highly accurate and precise reference method.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods are typically relevant for studies where human interpretation of data (e.g., images) forms the ground truth or is being evaluated for consistency. In this case, the comparisons are against established quantitative analytical methods (LC/MS/MS and a predicate immunoassay), where the result is a numerical value directly from the instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human interpretation of medical images or other data. The Emit® 2000 Tacrolimus Assay is an in vitro diagnostic test that provides a quantitative result directly, not a system designed for human-in-the-loop assistance for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The entire study focuses on the "algorithm only" (the Emit® 2000 Tacrolimus Assay) performance by comparing its quantitative output to other analytical methods. The device provides a direct numerical result without human interpretation being part of its core function or an evaluated human-in-the-loop workflow.

7. The Type of Ground Truth Used

The ground truth used for comparison was established by:

Liquid Chromatography/Mass Spectrometry (LC/MS/MS): This is a highly accurate and precise analytical method often considered the gold standard for quantitative measurements of tacrolimus.
Abbott IMx® Tacrolimus II Assay: This is a legally marketed predicate device, recognized as an established method for tacrolimus testing.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. Immunoassays like the Emit® 2000 Tacrolimus Assay are developed through chemical and biological engineering, not typically 'trained' in the same way machine learning algorithms are. The provided data represents validation against existing methods.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for this type of IVD device, this information is not applicable/provided. The ground truth for validation was established by LC/MS/MS and the predicate device.

Summary

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K060385

Dade Behring Inc. 510(k) Premarket Notification e-submission 510(x) Premail.co. Homes Assay and Emit® 2000 Tacrolimus Sample Pretreatment Reagent

510(k) Summary Emit® 2000 Tacrolimus Assay Emit® 2000 Tacrolimus Sample Pretreatment Reagent

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation

Manufacturer:

Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014

Contact Information:

Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Yuk-Ting Lewis Tel: 302-631-7626

Date of Preparation:

February 7, 2006

Device Name / Classification 2.

Emit® 2000 Tacrolimus Assay / Class II Emit@ 2000 Tacrolimus Sample Pretreatment Reagent / Class II

3. Identification of the Predicate Device

Abbott IMx® Tacrolimus II Assay and Pretreatment Reagent, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.)

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Dade Behring Inc. 510/k) Premarket Notification e-submission Emit® 2000 Tacrolimus Assay and Emit® 2000 Tacrolimus Sample Pretreatment Reagent

4. Device Description

5. Device Intended Use

The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.

Medical device to which equivalence is claimed and comparison information 6.

The Emit® 2000 Tacrolimus Assay and EMIT® 2000 Pretreatment Reagent are substantially equivalent in intended use and technological characteristics to the Abbott IMx® Tacrolimus II Assay and Pretreatment Reagent. Both devices are immunoassays intended for use in the quantitative measurement of tacrolimus in human whole blood. Both devices require a manual pretreatment. The Emit® 2000 Tacrolimus Assay has an assay range of 2-30 ng/mL. The Abbott IMx Tacrolimus II Assay has an assay range of 1.5-30 ng/mL.

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Dade Behring Inc. 510(k) Premarket Notification e-submission Emit® 2000 Tacrolimus Assay and Emit® 2000 Tacrolimus Sample Pretreatment Reagent

Comparison Information

Method comparison studies were conducted at two external sites comparing the Emit® 2000 Tacrolimus Assay against two predicates:

liquid chromatography / mass spectrometry (LC/MS) and .
. Abbott IMx® Tacrolimus II Assay.

Samples from 2 transplant groups (liver and kidney) were included in the studies. The data from both sites were pooled and analyzed by linear regression.

Comparative Method
LC/MS/MS	Slope	Intercept	r	n
All samples	1.15	-0.33	0.940	197
Kidney	1.10	-0.12	0.899	90
Liver	1.01	0.35	0.946	65
Abbott IMx® Tacrolimus II Assay
All samples	0.92	-0.04	0.881	192
Kidney	0.79	0.87	0.863	88
Liver	0.83	0.69	0.812	62

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

6 2006 APR

Ms. Yuk-Ting Lewis Regulatory Affairs & Compliance Manager Dade Behring Inc. P.O. Box 6101, M/S 514 Newark DE 19714-6101

Re: K060385

Trade/Device Name: Emit®2000 Tacrolimus Assay Emit®2000 Tacrolimus Sample Pretreatment Reagent Regulation Number: 21 CFR§ 862.1678 Regulation Name: Tacrolimus test system Regulatory Class: Class II Product Code: MLM Dated: February 10, 2006 Received: February 14, 2006

Dear Ms. Lewis:

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 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 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) 276-0484. 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 Act 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/cdrh/industry/support/index.html.

Sincerely vours.

Alberto G

Alberto Gutierrez, Ph.D. 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

k 060388 510(k) Number (if known):

Emit® 2000 Tacrolimus Assay Device Name: Emit® 2000 Tacrolimus Sample Pretreatment Reagent

Indications For Use:

The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

C.J.C.

e of In Vito Diagnostic Device bation and Safety

060385

Page I of I

Regulation Number and Section

§ 862.1678 Tacrolimus test system.

(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.