ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Device Facts
| Record ID | K201494 |
|---|---|
| Device Name | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
| Applicant | Advin Biotech, Inc. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Sep 17, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
The Advin Biotech ATTEST Drug Screens are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows: [Table omitted for brevity]. The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format or in the cup format. Only one cutoff concentration per analyte will be included per device. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. To obtained a confirmed analytical result, a more specific alternative chemical method should be used. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Device Story
The ATTEST Drug Screen Cup and Dip Card are lateral flow immunoassays for qualitative detection of drugs of abuse in human urine. The device uses competitive binding: drug-protein conjugates on a nitrocellulose membrane compete with target drugs in the urine for limited antibody sites. If target drugs are below the cutoff, antibody-colloidal gold conjugates bind to the membrane, forming a visible line (negative result). If target drugs exceed the cutoff, they saturate the antibodies, preventing line formation (preliminary positive result). The device is intended for prescription use by healthcare professionals. Results are visual and preliminary; positive results require confirmation via GC/MS or LC/MS. The device aids in clinical decision-making by providing rapid screening for drug presence, allowing for subsequent confirmatory testing and clinical evaluation.
Clinical Evidence
Bench testing only. Precision study conducted at three sites using 20 replicates per concentration level (±100%, ±75%, ±50%, ±25% and cutoff). Method comparison performed against LC/MS using clinical urine specimens; THC-20 assay showed 98.55% agreement for negative samples and 96.30% for positive samples. Interference testing confirmed no impact from endogenous agents, pH (4-9), or specific gravity (1.003-1.030).
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: integrated cup or dip card. Analyte detection via antibody-colloidal gold conjugate. Qualitative output; visual interpretation of T and C lines. No external energy source required. Stability: 28 months.
Indications for Use
Indicated for the qualitative detection of drugs of abuse and their metabolites in human urine for prescription use. Target analytes include 6-Acetylmorphine, Amphetamine, Secobarbital, Oxazepam, Buprenorphine, EDDP, Cocaine, Ecstasy, Methamphetamine, Marijuana, Methadone, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and Nortriptyline at specified cutoff concentrations.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Advin Multi-Drug Screen Test Cassette, Dip Card And Cup (K122809)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K201494
B Applicant
Advin Biotech, Inc.
C Proprietary and Established Names
ATTEST Drug Screen Cup ATTEST Drug Screen Dip Card
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |
| NGG | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| JXM | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| DIS | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| JXN | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
| DJR | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LFG | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
## II Submission/Device Overview:
### A Purpose for Submission:
Addition of new cutoff of 20ng/mL for THC-COOH (Marijuana 20) to a previously cleared device (K182123).
### B Measurand:
6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH
### C Type of Test:
Qualitative lateral-flow immunoassay
## III Intended Use/Indications for Use:
### A Intended Use(s):
The ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card are rapid lateral flow immunoassays for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:
| Assay | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
| --- | --- | --- | --- |
| 6-Acetylmorphine | 6AM | 6-monoacetylmorphine | 10 |
| Amphetamine | AMP | d-Amphetamine | 500 |
| Amphetamine | AMP | d-Amphetamine | 1,000 |
| Secobarbital | BAR | Secobarbital | 300 |
| Oxazepam | BZO | Oxazepam | 300 |
| Buprenorphine | BUP | Buprenorphine | 10 |
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| Assay | Abbreviation | Calibrator | Cutoff Concentration (ng/mL) |
| --- | --- | --- | --- |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl-3-3diphenylpyrrolidine | 300 |
| Cocaine | COC | Benzoylecgonine | 150 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Ecstasy | MDMA | d,l-Methylenedioxymethamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 500 |
| Methamphetamine | MET | d-Methamphetamine | 1,000 |
| Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 20 |
| Marijuana | THC | 11-nor-Δ⁹-THC-9-COOH | 50 |
| Methadone | MTD | d/l-Methadone | 300 |
| Opiates | OPI | Morphine | 300 |
| Opiates | OPI | Morphine | 2,000 |
| Oxycodone | OXY | Oxycodone | 100 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Propoxyphene | PPX | Propoxyphene | 300 |
| Nortriptyline | TCA | Nortriptyline | 1,000 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 16 analytes, with and without on-board adulteration/specimen validity tests (SVT) in the dip card format or in the cup format. Only one cutoff concentration per analyte will be included per device. The drug screen tests are intended for prescription use only.
The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result if the donor doesn't admit use or anytime required by testing procedures. Gas Chromatography / Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
B Indication(s) for Use:
Refer to intended use.
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C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For in vitro diagnostic use only.
D Special Instrument Requirements:
Not applicable.
IV Device/System Characteristics:
A Device Description:
The ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card devices are immunochromatographic assays that use a lateral flow system for the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH. There are two available test formats: integrated cup and dip card. Both formats utilize the same test strip. The ATTEST Drug Screen Cup device consists of a cup device and a package insert. The ATTEST Drug Screen Dip Card device consists of a Dip Card device, a package insert and a urine cup for sample collection.
B Principle of Operation:
The Advin Biotech ATTEST Drug Screen Cup and Dip Card are rapid lateral flow immunoassays, based on the principle of competitive binding, between a chemically labeled drug (drug-protein conjugate) and the drug or drug metabolites which may be present in the urine sample competing for the limited antibody binding sites. If target drugs are present in the urine specimen below the cut-off concentration of the assay, the solution of the colored antibody-colloidal gold conjugate that has been rehydrated by the urine sample migrates by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test (T) region. The colored antibody-gold conjugate then binds with the drug-protein conjugate to form visible lines in the test (T) regions. If the level of drug in the urine specimen is below the cutoff, the T line appears and if they are above the cutoff, no T line develops. A separate antibody-antigen reaction serves as an internal quality control as control line (C) line which must appear on the strip to interpret the results regardless of the presence of the drug.
V Substantial Equivalence Information:
A Predicate Device Name(s):
Advin Multi-Drug Screen Test Cassette, Dip Card And Cup
B Predicate 510(k) Number(s):
K122809
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K201494 | K122809 |
| --- | --- | --- |
| Device Trade Name | Advin Biotech
ATTEST Drug Screen
Cup and Dip Card | Advin Multi-Drug Screen Test
Cassette, Dip Card And Cup |
| General Device Characteristic Similarities | | |
| Intended Use/Indications for Use | Same | Qualitative detection of drugs of abuse and/or their metabolites in human urine |
| Methodology | Same | Lateral flow
immunochromatographic assay
based on competitive binding |
| Specimen | Same | Human urine |
| Test formats | Same | Cup and Dip Card |
| Intended use | Same | For Prescription Use Only |
| General Device Characteristic Differences | | |
| Analytes cutoffs (ng/mL) | Same except for the following analyte:
Marijuana- 20 | Amphetamine - 500
Amphetamine - 1,000
Barbiturates - 300
Benzodiazepine - 300
Buprenorphine - 10
Cocaine - 150
Cocaine - 300
EDDP - 300
Ecstasy - 500
Methamphetamine - 500
Methamphetamine - 1,000
Methadone - 300
Morphine - 300
Opiates - 2,000
Oxycodone - 100
Phencyclidine - 25
Propoxyphene - 300
Tricyclics - 1,000
Marijuana - 50 |
VI Standards/Guidance Documents Referenced:
Not applicable.
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VII Performance Characteristics (if/when applicable):
A Analytical Performance:
Analytical performance for 15 analytes, besides Marijuana-THC-COOH detected with a 20 ng/mL cutoff (6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/lMethylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, and Marijuana-THC-COOH at 50 ng/mL) were conducted on k122809 and k182123. The analytical performance of the device for the measurement of these analytes continues to be supported by data provided in k122809 and k182123.
1. Precision/Reproducibility:
The sponsor conducted a precision study for 11-nor-Δ9 -THC-COOH at three external sites. Eight participants tested nine (9) solutions containing ±100%, ±75%, ±50%, ±25% and cutoff levels of 11-nor-Δ9 -THC-COOH in twenty (20) replicates for each device format at each site.
Samples were prepared with drug free urine spiked with certified 11-nor-Δ9 -THC-COOH reference standards to the target concentrations. The samples contained following drug concentrations: negative, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff.
Precision Study Result of ATTEST Drug Screen Cup
| Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| THC 20 | Neg | 60 | 60 | 60 | 49 | 34 | 3 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 11 | 26 | 57 | 60 | 60 | 60 |
| | Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 |
| | Agreement | 100.00% | 100.00% | 100.00% | 81.67% | --- | 95.00% | 100.00% | 100.00% | 100.00% |
Precision Study Result of ATTEST Drug Screen Dip Card
| Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| THC 20 | Neg | 60 | 60 | 60 | 51 | 35 | 5 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 9 | 25 | 55 | 60 | 60 | 60 |
| | Total | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 |
| | Agreement | 100.00% | 100.00% | 100.00% | 85.00% | --- | 91.67% | 100.00% | 100.00% | 100.00% |
2. Linearity:
Not applicable. Devices intended for qualitative determinations only.
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# 3. Analytical Specificity/Interference:
Cross-reactivity: Analytical specificity for both the ATTEST Drug Screen Cup and the ATTEST Drug Screen Dip Card for each assay was determined by testing drug free urine samples spiked with certified standards of chemically-related or structurally-similar compounds. The relative cross-reactivity (if any) represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay.
Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.
Performance data for 6-Acetylmorphine devices (10 ng/mL cutoff, 6-AM 10), Amphetamine (1000 ng/mL cutoff, AMP 1000), Barbiturates, Benzodiazepines, Methadone (300 ng/mL cutoff), Cocaine (300 ng/mL cutoff, COC 300), EDDP (300 ng/mL cutoff), Methamphetamine (1000 ng/mL cutoff, MET 1000), Opiates (300 ng/mL cutoff, OPI 300), and Marijuana (50 ng/mL cutoff, THC-50) was provided in k182123.
| Assay/Cutoff | Compound | Concentration (ng/mL) | Relative cross reactivity (%) |
| --- | --- | --- | --- |
| THC 20 | 11-nor-Δ⁹-THC-COOH | 20 | 100 |
| | (±)-11-Hydroxy-Δ⁹-THC | 10,000 | 0.2 |
| | Δ⁸-THC | >100,000 | <0.02 |
| | Δ⁹-THC | 25,000 | 0.08 |
| | Cannabinol | >100,000 | <0.02 |
| | Cannabidiol (CBD) | >100,000 | <0.02 |
Interference: The potential interference (whether positive or negative) from compounds chemically dissimilar to target drugs, known endogenous agents, urine pH and specific gravity variances was also determined. Testing of compounds and endogenous agents was performed by spiking the substances into pooled urine containing target drugs at near-cutoff concentrations. Unless otherwise indicated, substances were tested for potential interference at concentrations of 100 µg/mL.
The following substances demonstrated no positive or negative interference on the assays encompassed in this submission when tested in samples bearing target drugs at +/-50% of stated cutoff.
| Acetaminophen | Acetone | Acetylsalicylic acid (aspirin) |
| --- | --- | --- |
| Albumin | Ampicillin | Ascorbic acid |
| Aspartame | Atropine | Benzocaine |
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| Bilirubin | Caffeine | Chloroquine |
| --- | --- | --- |
| Chlorpheniramine | Creatine | Dexbrompheniramine |
| Dextromethorphan | Dimethylaminoantipyrine | Diphenhydramine |
| Dimenhydrinate | Dopamine | Isoproterenol |
| (+)-Ephedrine | Erythromycin | Ethanol |
| Furosemide | Gabapentin | Glucose |
| Guaiacol glyceryl ether | Hemoglobin | Ibuprofen |
| Ketamine | Lidocaine | Methylephedrine |
| Naproxen | Niacinamide | Nicotine |
| Norephedrine | Oxalic acid | Pantoprazole |
| Penicillin-G | Pheniramine | Phenothiazine |
| l-Phenylephrine | B-Phenylethylamine | Pregabalin |
| Procaine | Quinidine | Ranitidine |
| Riboflavin | Sertraline | Sodium chloride |
| Sulindac | Theophylline | Tyramine |
To evaluate the potential effect of variances in urine pH on the assays, pooled urine specimens containing target drugs at near-cutoff concentrations were pH adjusted from 4.0 to 9.0 in increments of 1.0 and tested in duplicate.
To evaluate the potential effect of variances of urine specific gravity on the assays, pooled urine specimens containing target drugs at near-cutoff concentrations were diluted using deionized water or concentrated using sodium chloride to achieve specific gravity results of 1.003, 1.010, 1.015, 1.020, 1.025 and 1.030. Each solution was tested in duplicate.
The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.003 to 1.030 do not affect the results of the THC-20 assay.
Performance data for Amphetamine (500 ng/mL cutoff), Barbiturates, Benzodiazepines, Buprenorphine, EDDP, Cocaine (150 ng/mL cutoff), Ecstasy, Methamphetamine (500 ng/mL cutoff), Marijuana, Methadone, Opiates (2000 ng/mL cutoff), Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants was provided in k122809.
Performance data for 6-Acetylmorphine devices (10 ng/mL cutoff, 6-AM 10), Amphetamine (1000 ng/mL cutoff, AMP 1000), Barbiturates, Benzodiazepines, Methadone (300 ng/mL cutoff), Cocaine (300 ng/mL cutoff, COC 300), EDDP (300 ng/mL cutoff), Methamphetamine (1000 ng/mL cutoff, MET 1000), Opiates (300 ng/mL cutoff, OPI 300), and Marijuana (50ng/mL cutoff, THC-50) was provided in k182123.
4. Assay Reportable Range: Not applicable.
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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The Advin Biotech ATTEST Drug Screen Cup and Dip Card are traceable to a commercially available standard.
This device has internal process controls. A control (C) lines (lines from a separate antibody-antigen reaction forms appearing in the control region) confirms sufficient sample volume and proper test technique. The lack of a visible control (C) line indicates an insufficient specimen volume or improper test technique and the test must be repeated. There are no external controls supplied with the device.
Device stability has been evaluated through accelerated and real-time studies. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims that the devices are stable for 28 months.
6. Detection Limit:
Not applicable.
7. Assay Cut-Off:
For characterization of how the device performs analytically around the claimed cutoff concentration, please refer to section VII.A.1 and VII. B.1.
B Comparison Studies:
1. Method Comparison with Predicate Device:
The sponsor performed a method comparison study of the ATTEST Drug Screen Cup and Dip card using clinical urine specimens previously quantitated for THC-COOH by chemically specific quantitative methods (e.g., LC/MS). Identical results, provided in the table below, were obtained with the two devices. The results are shown in the table below. Method comparison studies demonstrating device accuracy when measuring previously cleared analytes can be found in K122809 and K182123.
| Drug Test/Cutoff (ng/mL) | Result | Drug free | Drug quantitation by chemically specific method relative to assay cutoff level | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | -50% C/O to <-25% C/O | -25% C/O to C/O | C/O to +25% C/O | >+25% C/O to +50% C/O | >+50% C/O | Agreement |
| THC/20 | Neg | 40 | 22 | 6 | 2 | 0 | 0 | 98.55% |
| | Pos | 0 | 0 | 1 | 1 | 5 | 46 | 96.30% |
Summary of Discordant Results, ATTEST Cup format
| Drug Test/ Cutoff (ng/ml) | ATTEST Cup Result | Result w/ GC/MS or LC/MS | |
| --- | --- | --- | --- |
| | | Drug Concentration (ng/ml) | Analyte |
| THC/20 | Positive | 17.4 | 11-nor-Δ9-THC-9-COOH |
| | Negative | 21.11 | 11-nor-Δ9-THC-9-COOH |
| | Negative | 22.55 | 11-nor-Δ9-THC-9-COOH |
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2. Matrix Comparison:
Not applicable. This assay is intended to be used with urine samples only.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
VIII Proposed Labeling:
The proposed labeling is deemed sufficient based on the outcomes of all intended user studies and meets the requirements of 21 CFR 809.10.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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