The Emit Calibrator/Controls are used in the callbration of the Emit II Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit Calibrator/Controls are used for the Emit II Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Mononclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays.

Device Description

The device is the Emit Calibrators' Controls , Lavels 0-5. The common or usual name is calibrators and/ or controls. The classification name is Clinical Toxicology Calibrator, 91 DKB. The Emit Calibrators/Controls contain various combinations of the following drugs at varying concentrations: benzoyecgonine, lormetazepam, methamphetamine, methaqualone, morphine, 11-delta 9-THC-9-COOH, phencyclidine, propoxyphene and secobarbital. They are intended to be used with the following respective Emit II Plus assays for detecting: eocaine metabolite, benzodiazepines, methadone, amphetamines, methaqualone, opiates, cannabinoids, phencyclidine, propoxyphene and barbiturates. The Emit Calibrators Controls are provided as ready-to-use liquids in a human urine matrix and they have characteristics common to a variety of commercially available calibrators and/or controls intended for use with assays for detecting drugs of-abuse. The do not have any expecially unique technical characteristics. Where applicable, calibrators include concentrations of analytes that are required by the US Substance Abuse and Mental Health Services Administration (SAMHSA) for detecting drugs-ofabuse. Nominal concentrations of each analyte are traceable to confirmation by GC/MS.

AI/ML Overview

The provided text is a 510(k) summary for the Dade Behring Emit Calibrators/Controls. This document focuses on the substantial equivalence of the device to previously marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not present in the provided text.

The document states: "Studies have shown that none of the analytes cross react or otherwise interfere with the use of any of the Emit II Plus assays for which these products are intended and that the products are sufficiently stable for their intended uses." This is a general statement about studies, but no specific data, acceptance criteria, or methodology are provided.

However, based on the information that is available, here's what can be extracted:

Acceptance Criteria and Study Details for Emit Calibrators/Controls

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
No specific performance acceptance criteria are mentioned for the calibrators/controls themselves, beyond being "sufficiently stable for their intended uses" and showing "no cross-reactivity or interference."	"Studies have shown that none of the analytes cross react or otherwise interfere with the use of any of the Emit II Plus assays for which these products are intended and that the products are sufficiently stable for their intended uses."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While it's a US-based submission, the location of the studies is not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/Not specified. The ground truth for the calibrators is based on chemical confirmation.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/Not specified.

5. 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

MRMC Study: No. This device is a calibrator/control, not an AI diagnostic system; therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a calibrator/control for assays, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The nominal concentrations of each analyte in the calibrators are established through confirmation by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate analytical chemistry technique used to identify and quantify substances within a sample, providing a definitive ground truth for the analyte concentrations.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. As a calibrator/control, the concept of a "training set" for an algorithm is not relevant.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. (See #8).

Summary

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DEC 2 1 1999

DADE BEHRING

P.2

SYVA COMPANY P.O. Box 49013 San Jose, CA 95161-9013

3403 Yerba Buena Road San Jose, CA 95135 Tel: +1 (408) 239-2000

510 (k) SUMMARY

This summary of $10(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

The assigned 510(k) number is:

The device is the Emit Calibrators' Controls , Lavels 0-5. The common or usual name is calibrators and/ or controls. The classification name is Clinical Toxicology Calibrator, 91 DKB.

The device is substantially equivalent to the following: Emit Calibrator Level O, Emit Calibrators A Level 1 and 2 and Emit Calibrators B Level 1 and 2.

The Emit Calibrators/Controls contain various combinations of the following drugs at varying concentrations: benzoyecgonine, lormetazepam, methamphetamine, methaqualone, morphine, 11-delta 9-THC-9-COOH, phencyclidine, propoxyphene and secobarbital. They are intended to be used with the following respective Emit II Plus assays for detecting: eocaine metabolite, benzodiazepines, methadone, amphetamines, methaqualone, opiates, cannabinoids, phencyclidine, propoxyphene and barbiturates.

The Emit Calibrators Controls are provided as ready-to-use liquids in a human urine matrix and they have characteristics common to a variety of commercially available calibrators and/or controls intended for use with assays for detecting drugs of-abuse. The do not have any expecially unique technical characteristics.

Where applicable, calibrators include concentrations of analytes that are required by the US Substance Abuse and Mental Health Services Administration (SAMHSA) for detecting drugs-ofabuse.

Nominal concentrations of each analyte are traceable to confirmation by GC/MS.

Studies have shown that none of the analytes cross react or otherwise interfere with the use of any of the Emit II Plus assays for which these products are intended and that the products are sufficiently stable for their intended uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

DEC 2 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul L. Rogers Jr. Senior Manager, Regulatory Affairs Syva Company 3403 Yerba Buena Road San Jose, California 95135

Re: K993755 Trade Name: Emit® Calibrator/Control Level 0 Emit® Calibrator/Control Level 1 Emit® Calibrator/Control Level 2 Emit® Calibrator/Control Level 3 Emit® Calibrator/Control Level 4 Emit® Calibrator/Control Level 5 Regulatory Class: II Product Code: DKB Regulatory Class: I Product Code: DIF Dated: November 4, 1999 Received: November 5, 1999

Dear Mr. Wells:

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 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). 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 (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 set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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Page 2

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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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 (if known): K993755

Device Name:

Emit® Calibrator/Control Level 0 Emit® Calibrator/Control Level 1 Emit® Calibrator/Control Level 2 Emit® Calibrator/Control Level 3 Emit® Calibrator/Control Level 4 Emit® Calibrator/Control Level 5

Indications for Use:

Note: The above listed assays are currently in the process of being filed for 510(k) clearance,

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Dean Cooper

Division Sign-Off) on of Clinical Laboratory Devices 55

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.