(175 days)
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS.
The Emit® II Plus 6-Acetylmorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectroscopy (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Emit® II Plus 6-AM/Ecstasy Calibrators/Controls:
When used as Calibrators, the materials are for the calibration of the Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assays.
When used as Controls, the materials may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs.
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is a homogenous enzyme immunoassay with a 10 ng/mL cutoff. The assay, used for the detection of 6-acetylmorphine (a heroin metabolite) in human urine, utilizes a two-reagent system. The Antibody/Substrate Reagent 1 is a liguid ready-to-use product comprised of mouse monoclonal antibodies to 6-acetylmorphine (6-AM), glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a lyophilized product containing 6-AM labeled bacterial recombinant glucose-6-phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), Hepes buffer, preservatives and stabilizers. Reagent 2 is reconstituted with either deionized or distilled water.
The assay kit consists of Reagent 1 and Reagent 2 in plastic containers (Reagent 2 is provided in a plastic bag with desiccant) and is available in two sizes. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 - 4:
The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are in-vitro diagnostic products used in the calibration of the Emit® II Plus 6-Acetylmorphine Assay and the Emit® II Plus Ecstasy Assay. These materials may also be used as quality controls based on the specific 6-Acetylmorphine Assay or Ecstasy Assay cutoffs.
The calibrator / control products have the same formulation as the existing Emit® II Plus Ecstasy Calibrators / Controls: cleared under K043028. The matrix is pooled, drug-free. human urine based product containing 6- acetylmorphine (6-AM), methylenedioxymethamphetamine (MDMA) and preservatives. The four levels of product are packaged separately in 15 mL plastic vials with a 10 mL fill per vial.
The multi-analyte Calibrators / Controls Levels 1 through 4 contain 6-AM and MDMA at the following concentrations:
Level 1: Targeted 6-AM Concentration (ng/mL) 5, Targeted MDMA Concentration (ng/mL) 150
Level 2: Targeted 6-AM Concentration (ng/mL) 10, Targeted MDMA Concentration (ng/mL) 300
Level 3: Targeted 6-AM Concentration (ng/mL) 15, Targeted MDMA Concentration (ng/mL) 500
Level 4: Targeted 6-AM Concentration (ng/mL) 20, Targeted MDMA Concentration (ng/mL) 1000
The Emit® Calibrator / Control Level 0, which contains no drug and was cleared under K993755 will also be used with the Emit® II Plus 6- AcetyImorphine Assay. There was no change to the Calibrator Level 0 product.
Acceptance Criteria and Device Performance for Emit® II Plus 6-Acetylmorphine Assay
The Emit® II Plus 6-Acetylmorphine Assay is an in-vitro diagnostic device designed for the qualitative and/or semiquantitative analysis of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. The device's performance was evaluated against a predicate device and confirmed using Gas Chromatography/Mass Spectrometry (GC/MS).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Emit® II Plus 6-Acetylmorphine Assay are implicitly defined by its agreement with GC/MS results for qualitative and semiquantitative analysis, particularly around the 10 ng/mL cutoff. The reported performance demonstrates high agreement with GC/MS.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Qualitative Agreement | High agreement (ideally >95%) with GC/MS for positive and negative samples, especially near the cutoff. | POS: 98% with GC/MS (for samples >= 10 ng/mL) NEG: 100% with GC/MS (for samples < 10 ng/mL) |
| Semiquantitative Agreement | High agreement with GC/MS, particularly for distinguishing between concentrations below and above the cutoff. | POS: 98% with GC/MS (for samples >= 10 ng/mL) NEG: 100% with GC/MS (for samples < 10 ng/mL) |
| Discordant Results | Minimal discordant results, with clear explanations for any discrepancies. | One discordant sample (#55): Emit® Assay semiquantitative result was 16.3 ng/mL (POS) while GC/MS was 7.8 ng/mL (NEG). |
2. Sample Size and Data Provenance
- Sample Size for Test Set: One-hundred five (105) unaltered human urine samples were used for the method comparison study.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "unaltered human urine samples," implying prospective collection for the study purpose, but this is not explicitly confirmed, nor is it stated whether the samples were de-identified or how they were handled.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), not by expert interpretation of the assay results.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The comparison was directly between the Emit® II Plus 6-Acetylmorphine Assay and GC/MS as the reference method. There was no mention of multiple readers or an adjudication process for the interpretation of the assay results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is not relevant for an automated diagnostic assay where human interpretation is not the primary output for diagnostic decision-making. The assay provides a quantitative/semiquantitative result.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Done: Yes. The reported performance metrics (qualitative and semiquantitative agreement with GC/MS) represent the standalone performance of the Emit® II Plus 6-Acetylmorphine Assay. There is no human-in-the-loop component mentioned that would alter the assay's output for diagnostic purposes.
7. Type of Ground Truth Used
- Type of Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). This is explicitly stated as "the preferred confirmatory method" and the method against which the Emit® II Plus 6-Acetylmorphine Assay was compared.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a comparison study for a fully developed diagnostic assay. Information regarding the development and training (if any, for internal algorithm optimization) of the immunoassay itself is not provided in this summary. This is a premarket notification for a predicate device, focusing on its performance characteristics.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as detailed training set information is not provided.
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MAR 1 8 2011
510(k) Summary of Safety and Effectiveness for the
Emit® II Plus 6-Acetylmorphine Assay
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 - 4
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR807.92.
A. 510(k) Number: K102779
B. Date of Preparation: March 1, 2011
C. Proprietary and Established Names
Emit® II Plus 6-Acetylmorphine Assay
Emit® II Plus 6-AM / Ecstasy Calibrator / Control Level 1 Emit® II Plus 6-AM / Ecstasy Calibrator / Control Level 2 Emit® II Plus 6-AM / Ecstasy Calibrator / Control Level 3 Emit® II Plus 6-AM / Ecstasy Calibrator / Control Level 4
D. Applicant:
Siemens Healthcare Diagnostics Inc.
P.O. Box 6101, Newark, DE 19714-6101
Janet Fose, Regulatory Technical Specialist, Regulatory Affairs
Office: (302) 631-8826 Fax: (302) 631-6299
E. Regulatory Information:
Emit® II Plus 6-Acetylmorphine Assay:
-
- Regulation section: 21 CFR § 862.3650 Opiate test system
-
- Classification: Class II
-
- Product Code: DJG Enzyme Immunoassay, Opiates
-
- Panel: Clinical Toxicology (91)
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 - 4:
Calibrator
-
- Regulation section: 21 CFR § 862.3200 Clinical toxicology calibrator
-
- Classification: Class II
-
- Product Code: DKB Calibrators, Drug Mixture
-
- Panel: Clinical Toxicology (91)
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Siemens Healthcare Diagnostics Inc. 510(k) Premarket Notification e-submission
Control
-
- Regulation section: 21 CFR § 862.3280 Clinical toxicology control material
-
- Classification: Class I. reserved
-
- Product Code: DIF Drug Mixture Control Materials
-
- Panel: Clinical Toxicology (91)
F. Predicate Device(s):
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is substantially equivalent to the Microgenics Corporation CEDIA® DAU 6-Acetylmorphine Assay cleared under K001178. Both are designed for use on a number of chemistry analyzers.
Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 - 4:
Calibrator
The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are substantially equivalent to the Emit® II Plus Ecstasy Calibrators / Controls cleared under K043028.
Control
The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are substantially equivalent to the Emit® II Plus Ecstasy Calibrators / Controls cleared under K043028. The Emit® Calibrator / Control Level 0, which was cleared under K993755 will also be used with the Emit® II Plus 6- Acetylmorphine Assay. There was no change to the Calibrator Level 0.
G. Device Description(s):
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is a homogenous enzyme immunoassay with a 10 ng/mL cutoff. The assay, used for the detection of 6-acetylmorphine (a heroin metabolite) in human urine, utilizes a two-reagent system. The Antibody/Substrate Reagent 1 is a liguid ready-to-use product comprised of mouse monoclonal antibodies to 6-acetylmorphine (6-AM), glucose-6-phosphate (G6P), and nicotinamide adenine dinucleotide (NAD) in a diluent containing bovine serum albumin (BSA), preservatives and stabilizers. The Enzyme Reagent 2 is a lyophilized product containing 6-AM labeled bacterial recombinant glucose-6-phosphate dehydrogenase (rG6PDH) in a diluent containing bovine serum albumin (BSA), Hepes buffer, preservatives and stabilizers. Reagent 2 is reconstituted with either deionized or distilled water.
The assay kit consists of Reagent 1 and Reagent 2 in plastic containers (Reagent 2 is provided in a plastic bag with desiccant) and is available in two sizes. Emit® II Plus Assays are designed for use with a number of chemistry analyzers.
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Emit® II Plus 6-AM / Ecstasy Calibrators / Controls Levels 1 - 4:
The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls are in-vitro diagnostic products used in the calibration of the Emit® II Plus 6-Acetylmorphine Assay and the Emit® II Plus Ecstasy Assay. These materials may also be used as quality controls based on the specific 6-Acetylmorphine Assay or Ecstasy Assay cutoffs.
The calibrator / control products have the same formulation as the existing Emit® II Plus Ecstasy Calibrators / Controls: cleared under K043028. The matrix is pooled, drug-free. human urine based product containing 6- acetylmorphine (6-AM), methylenedioxymethamphetamine (MDMA) and preservatives. The four levels of
product are packaged separately in 15 mL plastic vials with a 10 mL fill per vial.
The multi-analyte Calibrators / Controls Levels 1 through 4 contain 6-AM and MDMA at the following concentrations:
| Calibrator /Control | Targeted 6-AMConcentration(ng/mL) | Targeted MDMAConcentration(ng/mL) |
|---|---|---|
| Level 1 | 5 | 150 |
| Level 2 | 10 | 300 |
| Level 3 | 15 | 500 |
| Level 4 | 20 | 1000 |
The Emit® Calibrator / Control Level 0, which contains no drug and was cleared under K993755 will also be used with the Emit® II Plus 6-AcetyImorphine Assay. There was no change to the Calibrator Level 0 product.
H. Intended Use:
Emit® II Plus 6-Acetylmorphine Assay:
The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-A.M), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS.
The Emit® II Plus 6-Acetylmorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectroscopy (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
{3}------------------------------------------------
Emit® II Plus 6-AM/Ecstasy Calibrators/Controls:
When used as Calibrators, the materials are for the calibration of the Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assays.
When used as Controls, the materials may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs.
I. Substantial Equivalence Information:
The Emit® II Plus 6-AcetyImorphine Assay was compared to the Microgenics predicate device CEDIA® DAU 6-Acetylmorphine Assay (K001178). The Emit® II Plus 6-AM / Ecstasy Calibrators / Controls were compared to Siemens Healthcare Diagnostics Inc. Emit® II Plus Ecstasy Calibrators / Controls Levels 1 – 4 (K043028). A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:
| Feature | Proposed DeviceEmit® II Plus 6-Acetylmorphine Assay | PredicateCEDIA® DAU 6-Acetylmorphine Assay(K001178) |
|---|---|---|
| Intended Use | The Emit® II Plus 6-Acetylmorphine Assayis a homogeneous enzyme immunoassaywith 10 ng/mL cutoff. The assay isintended for use in laboratories for thequalitative and/or semiquantitative analysesof 6-acetylmorphine (6-AM), a heroinmetabolite, in human urine. Emit® II Plusassays are designed for use with a numberof chemistry analyzers.Semiquantitative test results may be used toassess assay performance as part of aquality control program and to estimate adilution of the specimen for confirmation byGC/MS.The Emit® II Plus 6-Acetylmorphine Assayprovides only a preliminary analytical testresult. A more specific alternative chemicalmethod must be used to obtain a confirmedanalytical result. Gas chromatography/massspectroscopy (GC/MS) is the preferredconfirmatory method. Other chemicalconfirmation methods are available.Clinical consideration and professionaljudgment should be applied to any drug-of-abuse test result, particularly whenpreliminary positive results are used. | The CEDIA® Heroin Metabolite(6-Acetylmorphine, or 6-AM)Assay is an in vitro diagnosticmedical device intended for thequalitative and semiquantitativeanalysis of heroin metabolite (6-AM) in human urine. *The assay provides only apreliminary analytical test result.A more specific alternatechemical method must be used toobtain a confirmed analyticalresult. Gas chromatography /mass spectrometry (GC/MS) isthe preferred confirmatorymethod. Clinical considerationand professional judgment shouldbe applied to any drug of abusetest result, particularly whenpreliminary positive results areobserved. **From the predicate device IFU |
Comparison of Assay Features
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. -- - - -
| PredicateCEDIA® DAU 6- | ||
|---|---|---|
| Feature | Proposed DeviceEmit® II Plus 6-Acetylmorphine Assay | Acetylmorphine Assay(K001178) |
| AssayMethodology | Homogeneous enzyme immunoassay usingEMIT® technology | Homogeneous enzymeimmunoassay using CEDIA®technology |
| Antibody | Mouse monoclonal antibodies to 6-AM | Monoclonal antibodies to 6-AM |
| ReferenceMethodology | GC / MS | GC / MS |
| Cutoff | 10 ng/mL | 10 ng/mL |
| Sample Type | Human urine | Human urine |
| Reagents:Form | R1: Liquid - Ready to UseR2: Lyophilized (Reconstitution required) | R1 & R2: Lyophilized(Reconstitutionrequired) |
| Stability(Reconstituted) | R1: Until Exp. on vialR2: 30 days | R1 & R2: 60 days |
| Instrument | Chemistry analyzers capable of maintainingconstant reaction temperature, pipettingspecimens/reagents and measuring enzymerates at 340 nm, timing reaction accuratelyand mixing reagent thoroughly | Clinical chemistry analyzerscapable of maintaining constanttemperature, pipetting samples,mixing reagents, measuringenzymatic rates at 570 nm andtiming the reaction accurately |
.
Comparison of Calibrator Features
| Proposed DeviceEmit® II Plus 6-AM / EcstasyCalibrators / Controls | PredicateEmit® II Plus Ecstasy Calibrators /Controls (K043028) | |
|---|---|---|
| Feature | ||
| Indications forUse | Calibrators are used in the calibration ofthe Emit® II Plus 6-Acetylmorphineand Emit® II Plus Ecstasy Assays. | The Emit® II Plus EcstasyCalibrators/ Controls are used in thecalibration of the Emit® II PlusEcstasy Assay. These standards mayalso be used as quality controlmaterials based on the specificEcstasy Assay cutoff. |
| Matrix | Human urine based | Human urine based |
| Analyte | Contains 6-AM and MDMA | Contains MDMA |
| TargetConcentrationsfor 6-AM | Level 1: 5 ng/mLLevel 2: 10 ng/mLLevel 3: 15 ng/mLLevel 4: 20 ng/mL | None |
| Preparation | Liquid -- Ready to Use | Liquid - Ready to Use |
| Storage | 2 – 8°C | 2 – 8°C |
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| Feature | Proposed DeviceEmit® II Plus 6-AM / EcstasyCalibrators / Controls | PredicateEmit® II Plus Ecstasy Calibrators /Controls (K043028) |
|---|---|---|
| Indications ForUse | Controls may be used as quality controlmaterials based on the specific Emit® IIPlus 6-Acetylmorphine and Emit® IIPlus Ecstasy Assay cutoffs. | The Emit® II Plus EcstasyCalibrators / Controls are used in thecalibration of the Emit® II PlusEcstasy Assay. These standards mayalso be used as quality controlmaterials based upon the specificEcstasy Assay cutoff. |
| Analyte | Contains 6-AM and MDMA | Contains MDMA |
| PositiveQuality ControlLevel forQualitativeAnalysis | Level 4 | Level 4 |
Comparison of Control Features
J. Method Comparison:
Qualitative and Semiquantitative Results
Split sample method comparison was conducted and one-hundred five (105) unaltered human urine samples were analyzed by the Emit® II Plus 6-Acetylmorphine Assay vs. GC/MS. The results are presented below:
Emit® II Plus 6-Acetylmorphine Assay vs. GC/MS
| GCMS | ||||||
|---|---|---|---|---|---|---|
| LOW NEGLess than50% belowthe cutoff(<5 ng/mL) | NEGWithin 50% belowthe cutoff(5.0~9.9 ng/mL) | POSWithin 50% abovethe cutoff(10.0~ 15 ng/mL | HIGH POSGreater than50% abovethe cutoff(>15 ng/mL) | 0/0Agreement | ||
| Qualitative Summary | ||||||
| Emit® | POS | 0 | ો ર | ਤੇ ਕੇ | 98% | |
| NEG | 49 | ર્ભ | 0 | 0 | 100% | |
| Semiquantitative Summary | ||||||
| Emit® | POS | 0 | ો.રે | 34 | 98% | |
| NEG | ਧੇਰੇ | б | 0 | 0 | 100% |
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Discordant Result Summary
| Cutoff Value(10 ng/mL) | Qualitative Result(POS/NEG) | Semiquantitative Result(ng/mL) | ||
|---|---|---|---|---|
| Emit® Assav | GC/MS | Emit® Assay | GC/MS | |
| Sample # 55 | 16.3 | 7.8 |
K. Conclusion:
The information provided in this pre-market notification, demonstrates the Emit® II Plus 6- Acetylmorphine Assay and the Emit® 6-AM / Ecstasy Calibrators / Controls are substantially equivalent to the legally marketed predicate devices for their general intended use. Substantial equivalence was demonstrated through comparison of intended use and technological features to the commercially available predicate devices and confirmed by gas chromatography/mass spectrometry (GC/MS), an independent analytical method. The information given in this pre-market notification provides reasonable assurance that the Emit® II Plus 6- Acetylmorphine Assay and Calibrators /Controls are safe and effective for their stated intended use.
{7}------------------------------------------------
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics Inc. c/o Ms. Janet Fose Regulatory Technical Specialist. Regulatory Affairs P.O. Box 6101. Mailbox 514 Newark. DE 19714-6101
MAR : 8 2011
Re: K102779
Trade/Device Name: Emit® II Plus 6-Acetylmorphine Assay and Emit® II Plus 6-AM / Ecstasy Calibrator / Control Levels 1 - 4
Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DKB and DIF Dated: February 10, 2011 Received: February 11, 2011
Dear Ms. Fose:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (3011796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 mumber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. 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):
Device Name: Emit® II Plus 6-AcetyImorphine Assay Emit® II Plus 6-AM / Ecstasy Calibrator /Control Level 1 Emit® II Plus 6-AM / Ecstasy Calibrator /Control Level 2 Emit® II Plus 6-AM / Ecstasy Calibrator /Control Level 3 Emit® II Plus 6-AM / Ecstasy Calibrator /Control Level 4
Indications For Use:
Emit® II Plus 6-Acetylmorphine Assay
The Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with 10 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin metabolite, in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
Semiquantitative test results may be used to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by GC/MS.
The Emit® II Plus 6-Acetylmorphine Assay provides only a preliminary analytical test result. A more specific alternative chemical must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clincal consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Emit® II Plus 6-AM/Ecstasy Calibrators/Controls Calibrators are used in the calibration of the Emit® II Plus 6-AcetyImorphine and Emit® II Plus Ecstasy Assays.
Controls may be used as quality control materials based on the specific Emit® II Plus 6-Acetylmorphine and Emit® II Plus Ecstasy Assay cutoffs.
Prescription Use ______________________________________________________________________________________________________________________________________________________________________________ (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)
C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102779
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).