Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details the preparation of control solutions for drug testing and does not mention any computational or analytical functions that would involve AI or ML.

Therapeutic

No
The device is described as an "assayed control" for the determination of drugs of abuse in human urine on automated clinical chemistry analyzers, indicating its use for diagnostic purposes, not for treating conditions.

Diagnostic

No

This device is described as an "assayed control" for a Roche test system, meaning it is used to verify the performance of other diagnostic tests, not to diagnose conditions itself.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is a prepared solution of drugs or drug metabolites in human urine, with added preservatives and stabilizers. This indicates a physical, chemical product, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the controls are "for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine". This indicates the device is used in vitro (outside the body) to analyze a human specimen (urine) for diagnostic purposes (determining the presence and amount of drugs of abuse).
Device Description: The description details the preparation of the controls using drug-free human urine and added drugs/metabolites. This further confirms the in vitro nature of the device and its use with human biological material.
Anatomical Site: The specified anatomical site is "Human urine," which is a biological specimen analyzed in vitro.
Intended User / Care Setting: The intended user is "Automated clinical chemistry analyzers," which are instruments used in clinical laboratories for in vitro diagnostic testing.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (K070200) and name ("TDM Control Set") strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

All these factors align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.

The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.

The Control Set DAT III is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.

None of these above named products can be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). The package insert or method sheet for information regarding the controls has appropriate instructions for use with these assays.

The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

Product codes (comma separated list FDA assigned to the subject device)

DIF

Device Description

Control Set DAT I is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.

Control Set DAT I contains a mixture of 10 different drugs. Drug concentrations in are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

Control Set DAT II is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.

Control Set DAT II contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

Control Set DAT III is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.

Control Set DAT III contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

Control Set Amphetamine 1000 is prepared by the quantitative addition of damphetamine to drug-free human urine. Preservative is added to maintain product integrity.

Drug concentrations in Control Set Amphetamine 1000 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

Control Set Amphetamine 500 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity.

Drug concentrations in Control Set Amphetamine 500 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070200

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K080183

MAR 2 5 2008

	510(k) Summary
Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contact	Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
Office: (317) 521-7688
Fax: (317) 521-2324
	Contact Person: Dimitris Demirtzoglou
Date Prepared: January 23, 2008
2) Device name	Proprietary name:
a. Control Set DAT I
b. Control Set DAT II
c. Control Set DAT III
d. Control Set Amphetamine 1000
e. Control Set Amphetamine 500
3) Regulatory information	Applicable to each of the devices.
	Product Code:DIFProduct Code Name:Drug Mixture Control MaterialsDevice Class:Class IClassification panel:Clinical ToxicologyC.F.R section:862.3280 - Clinical Toxicology Control Material	Product Code:	DIF	Product Code Name:	Drug Mixture Control Materials	Device Class:	Class I	Classification panel:	Clinical Toxicology	C.F.R section:	862.3280 - Clinical Toxicology Control Material
Product Code:	DIF
Product Code Name:	Drug Mixture Control Materials
Device Class:	Class I
Classification panel:	Clinical Toxicology
C.F.R section:	862.3280 - Clinical Toxicology Control Material
4) Predicate devices	We claim substantial equivalence for each of the devices to the currently marketed TDM Control Set (K070200).

1

Control Set DAT I

Device Description

Control Set DAT I is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.

Control Set DAT I contains a mixture of 10 different drugs. Drug concentrations in are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

| Drug | Assay
Cutoff | Target Concentration
(ng/mL) | |
|--------------------------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d-
methamphetamine) | 500 | 375 | 625 |
| Barbiturates (secobarbital) | 200 | 150 | 250 |
| Benzodiazepines
(nordiazepam) | 300 | 225 | 375 |
| Cannabinoids (Δ9 THC-
COOH) | 50 | 37.5 | 62.5 |
| Cocaine (benzoylecgonine) | 150 | 113 | 188 |
| Methadone (dl-methadone) | 300 | 225 | 375 |
| Methaqualone
(methaqualone) | 300 | 225 | 375 |
| Opiates (d-morphine) | 2000 | 1500 | 2500 |
| PCP (phencyclidine) | 25 | 18.8 | 31.3 |
| Propoxyphene
(propoxyphene) | 300 | 225 | 375 |

Control Set DAT II

Control Set DAT II is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.

Control Set DAT II contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

| Drug | Assay
Cutoff | Target Concentration
(ng/mL) | |
|--------------------------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d-
methamphetamine) | 300 | 225 | 375 |
| Benzodiazepines
(nordiazepam) | 100 | 75 | 125 |
| Cannabinoids (Δ9 THC-
COOH) | 20 | 15 | 25 |
| Opiates (d-morphine) | 300 | 225 | 375 |

2

5) Device Control Set DAT III Description (continued) Control Set DAT III is prepared by the quantitative addition of drug or drug metabolite to drug-free human urine. Preservative and stabilizer are added to maintain product integrity.

Control Set DAT III contains a mixture of 4 different drugs. Drug concentrations in Control Set DAT II are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

| Drug | Assay
Cutoff | Target Concentration
(ng/mL) | |
|--------------------------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d-
methamphetamine) | 1000 | 750 | 1250 |
| Benzodiazepines
(nordiazepam) | 200 | 150 | 250 |
| Cannabinoids (Δ9 THC-
COOH) | 100 | 75 | 125 |
| Cocaine (benzoylecgonine) | 300 | 225 | 375 |

Control Set Amphetamine 1000

Control Set Amphetamine 1000 is prepared by the quantitative addition of damphetamine to drug-free human urine. Preservative is added to maintain product integrity.

Drug concentrations in Control Set Amphetamine 1000 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

| Drug | Assay
Cutoff | Target Concentration
(ng/mL) | |
|------------------|-----------------|---------------------------------|----------|
| | | PreciNeg | PreciPos |
| Amphetamines (d- | 1000 | 750 | 1250 |

3

5) Device	Control Set Amphetamine 500
Description
(continued)	Control Set Amphetamine 500 is prepared by the quantitative addition of d-amphetamine to drug-free human urine. Preservative is added to maintain product integrity.
	Drug concentrations in Control Set Amphetamine 500 are verified by gas chromatography/mass spectrometry (GC/MS). Target concentrations are established at ± 25% of the assay cutoff.

Drug	Assay Cutoff	Target Concentration (ng/mL)
		PreciNeg	PreciPos
Amphetamines (d-	500	375	625

4

6.) Intended Control Set DAT I

Use

The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers. This product cannot be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). Refer to the package insert or method sheet for information regarding the controls appropriate for use with these assays.

Control Set DAT II

The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers. This product cannot be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). Refer to the package insert or method sheet for information regarding the controls appropriate for use with these assays.

Control Set DAT III

The Control Set DAT III is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers. This product cannot be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). Refer to the package insert or method sheet for information regarding the controls appropriate for use with these assays.

Control Set Amphetamine 1000

The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

5

·

6.) Intended Use (continued)	Control Set Amphetamine 500
------------------------------	------------------------------------

The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

7.) Comparison to the Predicate Device	Below the similarities and differences between the Control Set DAT I, Control Set DAT II, Control Set DAT III, Control Set Amphetamine 1000, Control Set Amphetamine 500, and its predicate device TDM Control Set (K070200) are presented.
----------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Continued on next page

6

7.) Comparison to the Predicate Device (continued)

	New Device	Predicate Device
Item	Control Set DAT I	TDM Control Set
Intended Use	The Control Set DAT I is for use as an assayed
control in the Roche test system for the qualitative
and semiquantitative determination of drugs of
abuse in human urine on automated clinical
chemistry analyzers.
This product cannot be used with the Roche
Abuscreen OnLine assay for Amphetamines or the
COBAS INTEGRA Amphetamines cobas c pack
(AMPS). Refer to the package insert or method
sheet for information regarding the controls
appropriate for use with these assays.	The TDM Control Set is for use in quality control
by monitoring accuracy and precision for the
quantitative methods as specified in the value
sheet.
Analytes	Amphetamines (d-methamphetamine) Barbiturates (secobarbital) Benzodiazepines (nordiazepam) Cannabinoids (Δ9 THC-COOH) Cocaine (benzoylecgonine) Methadone (dl-methadone) Methaqualone (methaqualone) Opiates (d-morphine) PCP (phencyclidine) Propoxyphene (propoxyphene)	Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin.
Form	Liquid	Liquid
Traceability	GC/MS1	USP Standards
Matrix	Human urine based	Human serum based
Number of
Levels	2	3

'Gas Chromatography/Mass Spectrometry

7

7.) Comparison to the Predicate Device (continued)

	New Device	Predicate Device
Item	Control Set DAT II	TDM Control Set
Intended Use	The Control Set DAT II is for use as an assayed
control in the Roche test system for the qualitative
and semiquantitative determination of drugs of
abuse in human urine on automated clinical
chemistry analyzers.
This product cannot be used with the Roche
Abuscreen OnLine assay for Amphetamines or the
COBAS INTEGRA Amphetamines cobas c pack
(AMPS). Refer to the package insert or method
sheet for information regarding the controls
appropriate for use with these assays.	The TDM Control Set is for use in quality control
by monitoring accuracy and precision for the
quantitative methods as specified in the value
sheet.
Analytes	Amphetamines (d-methamphetamine)Benzodiazepines (nordiazepam)Cannabinoids (Δ9 THC-COOH)Opiates (d-morphine)	AcetaminophenAmikacinCarbamazepineDigoxinGentamicinLidocaineN-acetylprocainamidePhenobarbitalPhenytoinPrimidoneProcainamideQuinidineSalicylateTheophyllineTobramycinValproic acidVancoymcin.
Form	Liquid	Liquid
Traceability	GC/MS1	USP Standards
Matrix	Human urine based	Human serum based
Number of
Levels	2	3

'Gas Chromatography/Mass Spectrometry

8

7.) Comparison to the Predicate Device (continued)

	New Device	Predicate Device
Item	Control Set DAT III	TDM Control Set
Intended Use	The Control Set DAT III is for use as an assayed
control in the Roche test system for the qualitative
and semiquantitative determination of drugs of
abuse in human urine on automated clinical
chemistry analyzers.
This product cannot be used with the Roche
Abuscreen OnLine assay for Amphetamines or the
COBAS INTEGRA Amphetamines cobas c pack
(AMPS). Refer to the package insert or method
sheet for information regarding the controls
appropriate for use with these assays.	The TDM Control Set is for use in quality control
by monitoring accuracy and precision for the
quantitative methods as specified in the value
sheet.
Analytes	Amphetamines (d-methamphetamine) Benzodiazepines (nordiazepam) Cannabinoids (Δ9 THC-COOH) Cocaine (benzoylecgonine)	Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin.
Form	Liquid	Liquid
Traceability	GC/MS1	USP Standards
Matrix	Human urine based	Human serum based
Number of
Levels	2	3

1 Gas Chromatography/Mass Spectrometry

9

7.) Comparison to the Predicate Device (continued)

	New Device	Predicate Device
Item	Control Set Amphetamine 1000	TDM Control Set
Intended Use	The Control Set Amphetamine 1000 is for use as
an assayed control with the Roche Abuscreen
OnLine assay for Amphetamines and the COBAS
INTEGRA Amphetamines cobas c pack (AMPS)
for the qualitative and semiquantitative
determination of amphetamines in human urine on
automated clinical chemistry analyzers.	The TDM Control Set is for use in quality control
by monitoring accuracy and precision for the
quantitative methods as specified in the value
sheet.
Analytes	• Amphetamines (d-amphetamine)	• Acetaminophen
• Amikacin
• Carbamazepine
• Digoxin
• Gentamicin
• Lidocaine
• N-acetylprocainamide
• Phenobarbital
• Phenytoin
• Primidone
• Procainamide
• Quinidine
• Salicylate
• Theophylline
• Tobramycin
• Valproic acid
• Vancomycin.
Form	Liquid	Liquid
Traceability	GC/MS1	USP Standards
Matrix	Human urine based	Human serum based
Number of
Levels	2	3

'Gas Chromatography/Mass Spectrometry

.

10

7.) Comparison to the Predicate Device (continued)

	New Device	Predicate Device
Item	Control Set Amphetamine 500	TDM Control Set
Intended Use	The Control Set Amphetamine 500 is for use as an
assayed control with the Roche Abuscreen OnLine
assay for Amphetamines and the COBAS
INTEGRA Amphetamines cobas c pack (AMPS)
for the qualitative and semiquantitative
determination of amphetamines in human urine on
automated clinical chemistry analyzers.	The TDM Control Set is for use in quality control
by monitoring accuracy and precision for the
quantitative methods as specified in the value
sheet.
Analytes	Amphetamines (d-amphetamine)	Acetaminophen Amikacin Carbamazepine Digoxin Gentamicin Lidocaine N-acetylprocainamide Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Tobramycin Valproic acid Vancomycin.
Form	Liquid	Liquid
Traceability	GC/MS1	USP Standards
Matrix	Human urine based	Human serum based
Number of
Levels	2	3

Gas Chromatography/Mass Spectrometry

11

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Mr. Dimitris Demirtzoglou Regulatory Affairs Consultant 9115 Hague Road, P.O. Box 50416 Indianapolis. IN 46250

MAR 2 5 2008

K080183 Re:

Trade Name: Control Set Dat I, Control Set Dat II, Control Set Dat III, Control Set Amphetamine 1000, Control Set Amphetamine 500 Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I, reserved Product Codes: DIF Dated: January 23, 2008 Received: January 25, 2008

Dear Mr. Demirtzoglou:

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).

12

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.v.M.

Jean M. Cooper, M.S., 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

13

Indication for Use

510(k) Number (if known): K080183

Device Name: Control Set DAT I, Control Set DAT II, Control Set DAT III, Control Set Amphetamine 1000, Control Set Amphetamine 500

Indication For Use:

The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.

The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.

The Control Set DAT III is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use __ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080183

14

None of these above named products can be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). The package insert or method sheet for information regarding the controls has appropriate instructions for use with these assays.

The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C Benam
Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080183