The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

Device Description

Emit® 2000 Vancomycin Calibrators are liquid, six-level calibrators prepared from vancomycin, buffer and preservatives. The calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

AI/ML Overview

The provided text describes information about a medical device, the "Emit® 2000 Vancomycin Calibrators," and its 510(k) submission. However, it does not contain the detailed performance study information typically associated with acceptance criteria and a study proving a device meets those criteria for image-based diagnostic AI/ML products.

This document describes a calibrator device, which is used to calibrate an assay, rather than a diagnostic AI/ML system that directly analyzes data for diagnosis. The performance characteristics described are related to the stability and manufacturing consistency of the calibrator itself, not the diagnostic performance of an AI system.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or not provided in the context of this device.

Here's an attempt to extract relevant information and note what is unavailable:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description / Reported Performance
Intended Use	The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.
Substantial Equivalence	Substantially equivalent in intended use to the Emit® Vancomycin Calibrators (K881040). The modified Emit® 2000 Vancomycin Calibrators contain the same vancomycin concentrations as the currently marketed device. Both devices are intended for use in the calibration of human serum or plasma in conjunction with a Vancomycin Reagent.
Shelf Life Stability	Acceptance Criteria (Implied): No significant change in recovery over time. Reported Performance: Stability studies support no significant change in recovery for at least 13 months. The assignment of shelf life will be based on real-time data.
Preparation / Lot Consistency	Acceptance Criteria (Implied): Calibrator levels are adjusted as needed to match Emit® 2000 responses of a Master Lot. Reported Performance: Each new calibrator lot is tested in bulk and final container stages with 20 replicates at each calibrator level. These values are compared to a Master Lot.

Study Details

Sample size used for the test set and the data provenance:
- For Shelf Life Stability: "at least 3 lots of calibrators" were used, stored at 9°C with comparison to calibrator sets stored at -20°C. Data provenance is implied to be internal testing by Dade Behring Inc. (retrospective data from real-time monitoring).
- For Preparation / Lot Consistency: "20 replicates at each calibrator level" were tested for each new calibrator lot. Data provenance is implied to be internal manufacturing quality control by Dade Behring Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a calibrator, not a diagnostic device requiring expert interpretation of medical data. The "ground truth" for calibrators relates to their accurate concentration and stability.
Adjudication method (e.g. 2+1, 3+1, none) 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 is not an AI/ML-based diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this calibrator device is based on "standard gravimetric procedures" to prepare the calibrators with known vancomycin concentrations and then comparing the lot's response to a "Master Lot" for consistency.
The sample size for the training set: Not applicable in the context of an AI/ML training set. The descriptions relate to manufacturing and stability testing procedures.
How the ground truth for the training set was established: Not applicable.

Summary

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MAY 08 2002

K020845

Dade Behring Inc. Emit® 2000 Vancomycin Calibrators 510(k) Notification March 14, 2002

510(k) Summary For Emit® 2000 Vancomycin Calibrators

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

Manufacturer: Dade Behring Inc Syva Company 20400 Mariani Avenue Cupertino, CA 95014

Contact Information: Donna A. Wolf Dade Behring Inc. P. O. Box 6101 Newark, DE 19714 Phone: 302-631-0384 Fax: 302-631-6299 E-mail: wolfda@dadebehring.com

Device Name / Classification: 2. Emit® 2000 Vancomycin Calibrator: Class II (862.3200) Classification Number:

Calibrator, drug specific

Identification of the Legally Marketed Device: 3. Emit® Vancomycin Calibrator (K881040)

Device Description: 4.

Device Intended Use: 5.

The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

Medical device to which equivalence is claimed and comparison information: 6. The Emit® 2000 Vancomycin Calibrators are substantially equivalent in intended use to the Emit® Vancomycin Calibrators (K881040) currently marketed. The modified Emit® 2000 Vancomycin Calibrators contain the same vancomycin concentrations as the currently marketed device. Both devices are intended for use in the calibration of human serum or plasma in conjunction with a Vancomycin Reagent.

7. Device Performance Characteristics:

Stability:

Shelf life stability was evaluated by testing the calibrators at a minimum in duplicate, stored at 9°C, with comparison to calibrator sets stored at -20°C. The assignment of shelf life will be based on real time data from at least 3 lots of calibrators. To date, stability studies support no significant change in recovery for at least 13 months.

Preparation:

Emit® 2000 Vancomycin Calibrators (modified) are prepared by standard gravimetric procedures using a synthetic matrix with buffers and preservative which has been supplemented with commercially available vancomycin.

Each new calibrator lot is tested in bulk and final container stages with 20 replicates at each calibrator level. These values are compared to a Master Lot. Calibrator levels are adjusted as needed to match Emit® 2000 responses of the Master Lot calibrators.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with three lines extending from its head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 0 8 2002

Ms. Donna A. Wolf Sr. Regulatory Affairs Specialist Dade Behring Inc. 514 GBC Drive Newark, DE 19702

Re: K020845

Trade/Device Name: Emit® 2000 Vancomycin Calibrators Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: March 14, 2002 Received: March 15, 2002

Dear Ms. Wolf:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his leation. The FDA finding of substantial equivalence of your device to a legally marketed nouticate 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 1 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, (301) 59 . 1500 . 1500 . 1500 . 16301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Dade Behring Inc. Emit® 2000 Vancomycin Calibrators 510(k) Notification March 14, 2002

Indications For Use Statement

Device Name: Emit® 2000 Vancomycin Calibrators

Indications for Use:

The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 The Ellines 2005 as a reference for use in determining vancomycin levels in human serum or plasma.

Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Levices 1020 વ્યવસ 510(k) Number ..

Donna A. Wolf Sr. Regulatory Affairs Specialist March 14, 2002

(Optional format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR Over-the-counter Use__

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.