The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

Device Description

The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.

AI/ML Overview

The provided document is a 510(k) summary for a drug of abuse calibrator/control device (Preciset® DAT Amphetamine). It's important to note that this device is a calibrator/control for an assay, not the assay itself or a diagnostic device that directly determines patient outcomes. Therefore, the "acceptance criteria" and "device performance" are related to the stability and functionality of the calibrator/control with respect to the assays it's intended to calibrate. The document does not describe a clinical study comparing human readers with and without AI assistance, nor does it detail a standalone algorithm performance for diagnostic purposes.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format but describes performance in terms of stability and functionality with the target assays.

Acceptance Criteria Category	Specific Criteria (Implicit from text)	Reported Device Performance Statement
Stability	The calibrator/control should maintain its intended concentration levels and performance over its shelf life and after opening.	"Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators/controls."
Functionality	The calibrator/control should perform effectively for the calibration of specified assays (Roche Abuscreen® OnLine assays for Amphetamines and COBAS INTEGRA® Amphetamines (AMPS)).	"When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use."
Equivalence	Substantial equivalence to a legally marketed predicate device.	"The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit® Calibrators/controls manufactured by Syva Company. Both feature similar matrices, constituents and stability claims."

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

The document does not specify a "test set" in the context of patient data or clinical samples that would require a sample size. It refers to stability studies and testing with immunoassays.

Sample Size for Test Set: Not applicable in the context of typical diagnostic device studies. The "test set" here refers to the calibrator/control vials themselves that were subjected to stability testing and functional evaluation with the specified assays. The number of such vials is not provided.
Data Provenance: Not applicable in the context of patient data. The studies were laboratory-based (accelerated and real-time stability studies) performed by the manufacturer, Quantimetrix Corporation. There is no mention of country of origin of data in terms of patient samples, as this is a calibrator/control device. The studies were prospective in nature (designed to validate claims).

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

This section is not applicable for this type of device. Ground truth in the context of diagnostic devices usually refers to a definitive diagnosis or condition established by clinical experts or gold standard methods (e.g., pathology, follow-up). For a calibrator/control, the "ground truth" for the drug concentration is established through analytical methods like GC/MS.

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

This section is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among expert readers in diagnostic image or clinical data interpretation. For a calibrator, the "truth" of its concentration is chemically determined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting diagnostic cases, often with and without AI assistance, to measure the impact of AI on reader performance. This device is a calibrator/control, not an AI diagnostic tool.

Effect size of human readers improving with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study as typically understood for AI diagnostic devices was not done. This device is a chemical calibrator/control, not an algorithm. The performance described relates to its stability and its ability to function correctly with specific immunoassay systems.

7. Type of Ground Truth Used:

For assessing the concentration of the drug (d-amphetamine) in the calibrator/control, the ground truth was established using an analytical reference method.

Ground Truth Type: Drug concentration determined using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and precise analytical chemistry technique used for quantifying substances.

8. Sample Size for the Training Set

This section is not applicable. This device is a calibrator/control, not a machine learning or AI model that requires a "training set" of data.

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

This section is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Quantimetrix Corporation. The logo consists of two overlapping circles with the letters "QC" inside, followed by the words "Quantimetrix Corporation" in a smaller font. Below the logo is the address "2005 Manhattan Beach Boulevard, Redondo Beach, CA 90278-1205".

TEL (800) 624-8380 or (310) 536-0006
FAX (800) 845-1834 or (310) 536-9977

510(K) SUMMARY

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

K 0308 210 The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

Proprietary Name:	Preciset® DAT Amphetamine
Common Name:	Calibrators/Controls
Classification Name:	Calibrators, Drug Mixture
Medical specialty:	Clinical Toxicology
Product Code:	DKB
Device class:	2
Regulation No:	862.3200
Manufacturer:	Quantimetrix Corporation2005 Manhattan Beach BoulevardRedondo Beach CA 90278Phone: 310/536-0006 FAX: 310/536-9977
Contact Persons:	Gebhard Neyer, Ph.D., Director of R&D, 310-536-0006
Registration No:	2020715

Drug concentration is determined using GC/MS. The Quantimetrix calibrator is substantially equivalent to the currently marketed Emit®

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Calibrators/controls manufactured by Syva Company.

Both feature similar matrices, constituents and stability claims.

Intended Use

Performance Characteristics

Accelerated stability studies (25°C and 37°C) and real time studies were performed to validate the shelf life claim and the opened vial claim of the calibrators/controls. When tested with the Roche immunoassays (currently under development) the calibrators were found to perform well and to be sufficiently stable for their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 3 2003

Gebhard Neyer, Ph.D. Director, Research & Development Quantimetrix Corporation 2005 Manhattan Beach Boulevard Redondo Beach, CA 90278

Re: K030826

Trade/Device Name: Preciset® DAT Amphetamine Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DIJ Dated: March 3, 2003 Received: March 14, 2003

Dear Dr. Neyer:

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. Iisting 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page_1_of_____________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): 40308080

Device Name: _____________ Preciset® DAT Amphetamine

Preciset® DAT Amphetamine

Drug of Abuse Calibrators/Controls

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K030826

Prescription Use	✓	OR	Over-The-Counter Use
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(Per 21 CFR 801.109) (Optional Format 1-2-96)(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3550 Lead test system.

(a)
Identification. A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.(b)
Classification. Class II.