Each configuration of the MGC DAU Control Sets is prepared in a human wine matrix, with stabilizers and preservatives added. As is shown in the table below, the MGC DAU Control Set is offered in three configurations differing only in the concentration and number of analytes offered.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "MGC DAU Control Sets: Primary, Clinical and Select," which are drug mixture control materials. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one might for an AI/ML diagnostic device.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable (N/A) in this context, as this submission is for a quality control material and relies on demonstrating similar physical properties and intended use to a previously cleared device.

Here's a breakdown based on the provided text, indicating N/A where information is not present or relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present a formal table of quantitative acceptance criteria and corresponding reported performance data in the typical sense of a diagnostic or therapeutic device. Instead, it relies on a qualitative comparison of characteristics to a predicate device to establish substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (MGC DAU Control Sets)
Intended Use	For use as unassayed control material with drugs of abuse assays.	The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine. (Substantially equivalent)
Analytes	Benzoylecgonine, EDDP, LSD, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, Barbituates (as per predicate's list).	Primary Config: Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Methaqualone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, BarbituatesClinical Config: Benzoylecgonine, EDDP, d-Methamphetamine, Methadone, Opiates, Benzodiazepenes, Phencyclidine, Propoxyphene, BarbituatesSelect Config: 6-Acetylmorphine, Benzoylecgonine, LSD, MDMA, Benzodiazepenes(Variations exist, but presented as acceptable configurations for "stated intended use" via substantial equivalence).
Matrix	Urine	Urine (Substantially equivalent)
Control Form	Liquid	Liquid (Substantially equivalent)
Control Levels	Two: Low and High	Two: Low and High (Substantially equivalent) (Specific concentrations are provided for the subject device in a table, implying they were tested and found suitable for the stated purpose within the context of their intended use, which is validation of assays, not necessarily diagnostic accuracy performance).
Storage	2°C to 8°C until expiration date	2°C to 8°C until expiration date (Substantially equivalent)
Stability	Until expiration date noted on vial label	Until expiration date noted on vial label (Substantially equivalent)

Note: The "acceptance criteria" here are implicitly met by demonstrating that the device characteristics are "substantially equivalent" to those of a legally marketed predicate device (Multi-Drug Control Set, K951135). The study in this context is the comparison itself, showing that "each configuration of the MGC DAU Control Set is substantially equivalent in form and function to the Multi-Drug Control Set (K951135) for its stated intended use."

2. Sample size used for the test set and the data provenance

This submission does not describe a traditional "test set" in the context of diagnostic accuracy or algorithm performance. The evaluation is a comparison of device characteristics and intended use to a predicate device. There are no "samples" of patient data or images. The "data provenance" is the manufacturer's internal characterization of their product and comparison to their previously cleared product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a quality control material submission, not an AI/ML diagnostic. There's no ground truth established by experts for a test set in this context. The "truth" is related to the chemical composition and stability of the control materials, which are characterized through laboratory methods by the manufacturer.

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

N/A. No adjudication method is applicable as there's no diagnostic test set with human interpretations requiring consensus.

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

N/A. This is a quality control product, not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant.

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

N/A. This is not an algorithm or an AI device.

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

For a device like this, the "ground truth" for the control materials themselves would be their assigned target concentrations (expected values) and their stability characteristics, which are determined through highly controlled analytical chemistry methods and manufacturing processes, rather than expert consensus on clinical cases, pathology, or outcomes data. The submission relies on the established safety and effectiveness of a predicate device with similar "ground truth" generation.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a training set.

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

N/A. This is not an AI/ML device.

Summary

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SECTION II

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.

510(k) Number: K646758

Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Preparation Date:

March 23, 2004

Device Information:

Device Classification Name:	Drug Mixture Control Materials
Device Description	Clinical toxicology control material
Proprietary Name:	MGC DAU Control Sets: Primary, Clinical and Select
Regulation Number:	21 CFR§862.3280
Product Code:	DIF
Regulatory Class:	Class I

Predicate Devices:

Evaluation of the data and results enclosed herein demonstrate that each configuration of the MGC DAU Control Sets is substantially equivalent in form and function to the Muli-Drug Control Set (K951135) for its stated intended use.

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Device Description:

Configuration	Drug	Low (ng/mL)	High (ng/mL)
Primary	Benzoylecgonine	225	375
	EDDP	750	1250
	d-Methamphetamine	750	1250
	Methadone	225	375
	Methaqualone	225	375
	Opiates	1500	2500
	Benzodiazepenes	225	375
	Phencyclidine	19	31
	Propoxyphene	225	375
	Barbituates	225	375
Clinical	Benzoylecgonine	225	375
	EDDP	75	125
	d-Methamphetamine	375	625
	Methadone	225	375
	Methaqualone	225	375
	Opiates	225	375
	Benzodiazepenes	225	375
	Phencyclidine	19	31
	Propoxyphene	225	375
	Barbituates	225	375
Select	6-Acetylmorphine	7.5	12.5
	Benzoylecgonine	112.5	187.5
	LSD	0.3	0.7
	MDMA	375	625
	Benzodiazepenes	225	375

Intended Use:

The MGC DAU Control Set consists of unassayed controls intended for use in the validation of drug of abuse assays performed using human urine.

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Comparison to Predicate Device(s):

The MGC DAU Control Set is substantially equivalent to the Multi-Drug Control Set (K951135), also manufactured by Microgenics and previously cleared by FDA, for its stated intended use.

DeviceCharacteristics	Subject Device	Predicate Device (K951135)
Intended Use	The MGC DAU Control Set consistsof unassayed controls intended for usein the validation of drug of abuseassays performed using human urine.	The Multi-Drug Controls are for useas unassayed control material withdrugs of abuse assays.
Analytes(by configuration)	Primary:BenzoylecgonineEDDPd-MethamphetamineMethadoneMethaqualoneOpiates1Benzodiazapenes2PhencyclidinePropoxypheneBarbituates3Clinical:BenzoylecgonineEDDPd-MethamphetamineMethadoneOpiates1Benzodiazapenes2PhencyclidinePropoxypheneBarbituates3Select:6-AcetylmorphineBenzoylecgonineLSDMDMABenzodiazapenes4	BenzoylecgonineEDDPLSDd-MethamphetamineMethadoneMethaqualoneOpiates1Benzodiazapenes4PhencyclidinePropoxypheneBarbituates3
Matrix	Urine	Urine
Control Form	Liquid	Liquid
Control Levels	Two: Low and High	Two: Low and High
Storage	2°C to 8°C until expiration date	2°C to 8°C until expiration date
Stability	Until expiration date noted on viallabel	Until expiration date noted on viallabel

Morphine 2 Oxazepam Secobarbital Nitrazepam

Summary:

The information provided in this pre-market notification demonstrates that each configuration of the MGC DAU Control Set is substantially equivalent in form and function to the Multi-Drug Control Set (K951135) for its stated intended use. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate devices. The information supplied in

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this pre-market notification provides reasonable assurance that each configuration of the MGC DAU Control Set is safe and effective for its stated intended use.

September 19.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, which is the main emblem of the department.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 8 2004

David Casal, Ph.D Vice-President, Clinical, Regulatory and Quality Affairs Microgenics Corp. 46360 Fremont Blvd. Fremont, CA 94538

Rc: K040758

Trade/Device Name: MGC DAU Control Sets: Primary, Clinical and Select Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: March 23, 2004 Received: April 12, 2004

Dear Dr. Casal:

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 adultcration.

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.

Jean M. Cooper, US, Div.

Jean M. Cooper, MS. 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

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INDICATIONS FOR USE

510(k) Number (if known): K040758

MGC DAU Control Sets: Primary, Clinical and Select Device name:

Indications for Use:

The MGC DAU Control Set consists of controls intended for use in the validation of drug of abuse assays performed using human urine.

Prescription Use _ ಸ್ (Part 21 CFR §801 Subpart D) AND/OP.

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)

Dberto

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040758

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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.