(175 days)
No
The device description and performance studies describe a standard enzyme immunoassay and comparison to GC/MS, with no mention of AI or ML.
No.
This device is an in-vitro diagnostic product used for the qualitative and/or semiquantitative analysis of a drug metabolite in human urine, providing only a preliminary analytical test result. It is not designed to provide or deliver therapeutic benefit to a patient.
Yes
The Intended Use / Indications for Use section states, "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." This indicates its purpose is to analyze a substance in human urine, which is a diagnostic function.
No
The device description clearly states it is a "homogeneous enzyme immunoassay" utilizing a "two-reagent system" with liquid and lyophilized components in "plastic containers". This indicates a chemical assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM)... in human urine." This is a diagnostic test performed on a biological sample (urine) to detect a substance related to a medical condition or exposure (heroin metabolite).
- Device Description: The description details the reagents and components used to perform the assay, which are typical of in vitro diagnostic tests.
- Calibrators/Controls: The description of the calibrators and controls explicitly states they are "in-vitro diagnostic products used in the calibration... and may also be used as quality controls." This further confirms the IVD nature of the system.
- Performance Studies: The inclusion of performance studies comparing the assay to a reference method (GC/MS) is a standard requirement for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The listing of predicate devices with K numbers indicates that this device is being compared to previously cleared IVD devices.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DKB, DIF
Device Description
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:
| Calibrator /Control | Targeted 6-AM Concentration (ng/mL) | Targeted MDMA Concentration (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- Acetylmorphine Assay. There was no change to the Calibrator Level 0 product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories
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)
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.
Qualitative Summary for Emit® II Plus 6-Acetylmorphine Assay vs. GC/MS:
Emit® POS: 0 with LOW NEG (15 ng/mL). Agreement: 98%.
Emit® NEG: 49 with LOW NEG (15 ng/mL). Agreement: 100%.
Semiquantitative Summary for Emit® II Plus 6-Acetylmorphine Assay vs. GC/MS:
Emit® POS: 0 with LOW NEG (15 ng/mL). Agreement: 98%.
Emit® NEG: 48 with LOW NEG (15 ng/mL). Agreement: 100%.
Discordant Result Summary, Cutoff Value (10 ng/mL):
Sample # 55: Qualitative Result (POS/NEG) - Emit® Assay (Not specified), GC/MS (Not specified). Semiquantitative Result (ng/mL) - Emit® Assay (16.3), GC/MS (7.8).
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.
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.
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
§ 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).
0
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)
1
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.
2
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-AM
Concentration
(ng/mL) | Targeted MDMA
Concentration
(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 Device
Emit® II Plus 6-Acetylmorphine Assay | Predicate
CEDIA® DAU 6-
Acetylmorphine Assay
(K001178) |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | The CEDIA® Heroin Metabolite
(6-Acetylmorphine, or 6-AM)
Assay is an in vitro diagnostic
medical device intended for the
qualitative and semiquantitative
analysis of heroin metabolite (6-
AM) in human urine. *
The assay provides only a
preliminary analytical test result.
A more specific alternate
chemical method must be used to
obtain a confirmed analytical
result. Gas chromatography /
mass spectrometry (GC/MS) is
the preferred confirmatory
method. Clinical consideration
and professional judgment should
be applied to any drug of abuse
test result, particularly when
preliminary positive results are
observed. *
*From the predicate device IFU |
Comparison of Assay Features
4
. -- - - -
| | | Predicate
CEDIA® DAU 6- |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Proposed Device
Emit® II Plus 6-Acetylmorphine Assay | Acetylmorphine Assay
(K001178) |
| Assay
Methodology | Homogeneous enzyme immunoassay using
EMIT® technology | Homogeneous enzyme
immunoassay using CEDIA®
technology |
| Antibody | Mouse monoclonal antibodies to 6-AM | Monoclonal antibodies to 6-AM |
| Reference
Methodology | GC / MS | GC / MS |
| Cutoff | 10 ng/mL | 10 ng/mL |
| Sample Type | Human urine | Human urine |
| Reagents:
Form | R1: Liquid - Ready to Use
R2: Lyophilized (Reconstitution required) | R1 & R2: Lyophilized
(Reconstitution
required) |
| Stability
(Reconstituted) | R1: Until Exp. on vial
R2: 30 days | R1 & R2: 60 days |
| Instrument | Chemistry analyzers capable of maintaining
constant reaction temperature, pipetting
specimens/reagents and measuring enzyme
rates at 340 nm, timing reaction accurately
and mixing reagent thoroughly | Clinical chemistry analyzers
capable of maintaining constant
temperature, pipetting samples,
mixing reagents, measuring
enzymatic rates at 570 nm and
timing the reaction accurately |
.
Comparison of Calibrator Features
| | Proposed Device
Emit® II Plus 6-AM / Ecstasy
Calibrators / Controls | Predicate
Emit® II Plus Ecstasy Calibrators /
Controls (K043028) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | |
| Indications for
Use | Calibrators are used in the calibration of
the Emit® II Plus 6-Acetylmorphine
and Emit® II Plus Ecstasy Assays. | The Emit® II Plus Ecstasy
Calibrators/ Controls are used in the
calibration of the Emit® II Plus
Ecstasy Assay. These standards may
also be used as quality control
materials based on the specific
Ecstasy Assay cutoff. |
| Matrix | Human urine based | Human urine based |
| Analyte | Contains 6-AM and MDMA | Contains MDMA |
| Target
Concentrations
for 6-AM | Level 1: 5 ng/mL
Level 2: 10 ng/mL
Level 3: 15 ng/mL
Level 4: 20 ng/mL | None |
| Preparation | Liquid -- Ready to Use | Liquid - Ready to Use |
| Storage | 2 – 8°C | 2 – 8°C |
5
| Feature | Proposed Device
Emit® II Plus 6-AM / Ecstasy
Calibrators / Controls | Predicate
Emit® II Plus Ecstasy Calibrators /
Controls (K043028) |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | Controls may be used as quality control
materials based on the specific Emit® II
Plus 6-Acetylmorphine and Emit® II
Plus Ecstasy Assay cutoffs. | The Emit® II Plus Ecstasy
Calibrators / Controls are used in the
calibration of the Emit® II Plus
Ecstasy Assay. These standards may
also be used as quality control
materials based upon the specific
Ecstasy Assay cutoff. |
| Analyte | Contains 6-AM and MDMA | Contains MDMA |
| Positive
Quality Control
Level for
Qualitative
Analysis | 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 NEG | ||||||
| Less than | ||||||
| 50% below | ||||||
| the cutoff | ||||||
| (15 ng/mL) | 0/0 | |||||
| Agreement | ||||||
| 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% |
6
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).
8
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
9
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