(60 days)
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.
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.
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 d-amphetamine 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.
The provided documentation describes the Control Set DAT I, II, III, Control Set Amphetamine 1000, and Control Set Amphetamine 500 products as "Drug Mixture Control Materials." These are controls used to verify the performance of drug abuse testing systems. The "study" described is primarily focused on characterizing the control materials themselves, not a clinical study involving the device's diagnostic performance on patient samples.
Therefore, many of the typical acceptance criteria and study design elements for AI/diagnostic devices will not be applicable here. This document describes the creation and verification of the control materials.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these control sets are primarily defined by their target concentrations for various drugs, established as ±25% of the assay cutoff. The "reported device performance" in this context refers to the verification of these target concentrations using Gas Chromatography/Mass Spectrometry (GC/MS).
| Control Set | Drug | Assay Cutoff (ng/mL) | Target Concentration (PreciNeg ng/mL) | Target Concentration (PreciPos ng/mL) | Verification Method |
|---|---|---|---|---|---|
| Control Set DAT I | Amphetamines (d-methamphetamine) | 500 | 375 | 625 | GC/MS |
| Barbiturates (secobarbital) | 200 | 150 | 250 | GC/MS | |
| Benzodiazepines (nordiazepam) | 300 | 225 | 375 | GC/MS | |
| Cannabinoids (Δ9 THC-COOH) | 50 | 37.5 | 62.5 | GC/MS | |
| Cocaine (benzoylecgonine) | 150 | 113 | 188 | GC/MS | |
| Methadone (dl-methadone) | 300 | 225 | 375 | GC/MS | |
| Methaqualone (methaqualone) | 300 | 225 | 375 | GC/MS | |
| Opiates (d-morphine) | 2000 | 1500 | 2500 | GC/MS | |
| PCP (phencyclidine) | 25 | 18.8 | 31.3 | GC/MS | |
| Propoxyphene (propoxyphene) | 300 | 225 | 375 | GC/MS | |
| Control Set DAT II | Amphetamines (d-methamphetamine) | 300 | 225 | 375 | GC/MS |
| Benzodiazepines (nordiazepam) | 100 | 75 | 125 | GC/MS | |
| Cannabinoids (Δ9 THC-COOH) | 20 | 15 | 25 | GC/MS | |
| Opiates (d-morphine) | 300 | 225 | 375 | GC/MS | |
| Control Set DAT III | Amphetamines (d-methamphetamine) | 1000 | 750 | 1250 | GC/MS |
| Benzodiazepines (nordiazepam) | 200 | 150 | 250 | GC/MS | |
| Cannabinoids (Δ9 THC-COOH) | 100 | 75 | 125 | GC/MS | |
| Cocaine (benzoylecgonine) | 300 | 225 | 375 | GC/MS | |
| Control Set Amp. 1000 | Amphetamines (d-amphetamine) | 1000 | 750 | 1250 | GC/MS |
| Control Set Amp. 500 | Amphetamines (d-amphetamine) | 500 | 375 | 625 | GC/MS |
Note: The document states that drug concentrations are verified by GC/MS, implying that these target concentrations were successfully achieved and confirmed. Specific numerical results of this verification (e.g., actual measured concentrations and their variances) are not provided in this summary, only the target ranges.
Study Details (as applicable)
-
Sample size used for the test set and the data provenance: This document describes the preparation and verification of control materials, not a study evaluating a diagnostic device with patient samples. Therefore, there isn't a "test set" in the traditional sense of patient data. The "samples" are the control materials themselves, which are prepared from "drug-free human urine" with quantitative additions of specific drugs/metabolites. The provenance of the drug-free human urine or the origin of drug substances is not specified. It's a laboratory-prepared product.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the concentrations in the control materials is established by the quantitative addition of known amounts of drugs and then verified by GC/MS, an analytical chemistry technique. This does not involve human expert interpretation of a diagnostic outcome.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As this is not a diagnostic interpretation study, there is no adjudication process involving human experts.
-
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 document pertains to control materials for drug testing, not an AI-powered diagnostic device or a study involving human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. These are control materials, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the control materials is the known, quantitatively added concentrations of specific drugs/metabolites, verified by an analytical method (Gas Chromatography/Mass Spectrometry (GC/MS)).
-
The sample size for the training set: Not applicable. Control materials do not have a "training set" in the context of machine learning or diagnostic algorithm development.
-
How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
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 Corporation9115 Hague Rd.Indianapolis, IN 46250Office: (317) 521-7688Fax: (317) 521-2324 | ||||||||||
| Contact Person: Dimitris DemirtzoglouDate Prepared: January 23, 2008 | |||||||||||
| 2) Device name | Proprietary name:a. Control Set DAT Ib. Control Set DAT IIc. Control Set DAT IIId. Control Set Amphetamine 1000e. 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 | AssayCutoff | 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 | AssayCutoff | 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 | AssayCutoff | 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 | AssayCutoff | 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 assayedcontrol in the Roche test system for the qualitativeand semiquantitative determination of drugs ofabuse in human urine on automated clinicalchemistry analyzers.This product cannot be used with the RocheAbuscreen OnLine assay for Amphetamines or theCOBAS INTEGRA Amphetamines cobas c pack(AMPS). Refer to the package insert or methodsheet for information regarding the controlsappropriate for use with these assays. | The TDM Control Set is for use in quality controlby monitoring accuracy and precision for thequantitative methods as specified in the valuesheet. |
| 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 ofLevels | 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 assayedcontrol in the Roche test system for the qualitativeand semiquantitative determination of drugs ofabuse in human urine on automated clinicalchemistry analyzers.This product cannot be used with the RocheAbuscreen OnLine assay for Amphetamines or theCOBAS INTEGRA Amphetamines cobas c pack(AMPS). Refer to the package insert or methodsheet for information regarding the controlsappropriate for use with these assays. | The TDM Control Set is for use in quality controlby monitoring accuracy and precision for thequantitative methods as specified in the valuesheet. |
| 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 ofLevels | 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 assayedcontrol in the Roche test system for the qualitativeand semiquantitative determination of drugs ofabuse in human urine on automated clinicalchemistry analyzers.This product cannot be used with the RocheAbuscreen OnLine assay for Amphetamines or theCOBAS INTEGRA Amphetamines cobas c pack(AMPS). Refer to the package insert or methodsheet for information regarding the controlsappropriate for use with these assays. | The TDM Control Set is for use in quality controlby monitoring accuracy and precision for thequantitative methods as specified in the valuesheet. |
| 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 ofLevels | 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 asan assayed control with the Roche AbuscreenOnLine assay for Amphetamines and the COBASINTEGRA Amphetamines cobas c pack (AMPS)for the qualitative and semiquantitativedetermination of amphetamines in human urine onautomated clinical chemistry analyzers. | The TDM Control Set is for use in quality controlby monitoring accuracy and precision for thequantitative methods as specified in the valuesheet. |
| 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 ofLevels | 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 anassayed control with the Roche Abuscreen OnLineassay for Amphetamines and the COBASINTEGRA Amphetamines cobas c pack (AMPS)for the qualitative and semiquantitativedetermination of amphetamines in human urine onautomated clinical chemistry analyzers. | The TDM Control Set is for use in quality controlby monitoring accuracy and precision for thequantitative methods as specified in the valuesheet. |
| 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 ofLevels | 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
§ 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.