(67 days)
No
The description details a standard enzyme immunoassay for drug detection, which relies on chemical reactions and optical measurements, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
No.
The device is an in vitro diagnostic assay intended for the qualitative and semiquantitative analysis of amphetamines in human urine, which provides preliminary analytical test results for diagnostic purposes rather than directly treating or preventing disease.
Yes
Explanation: The device is intended for the "qualitative and semiquantitative analyses of amphetamines in human urine," which provides preliminary analytical test results to inform medical decisions. While it requires confirmation by other methods, its core function is to analyze biological samples to detect a substance, fitting the definition of a diagnostic device.
No
The device is described as a homogeneous enzyme immunoassay, which is a chemical assay requiring reagents and laboratory equipment (chemistry analyzers) to perform the test on urine specimens. This indicates it is a physical diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the assay is intended for "qualitative and semiquantitative analyses of amphetamines in human urine." This indicates the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (detecting amphetamines).
- Device Description: The "Device Description" further confirms this by stating it's a "homogeneous enzyme immunoassay for the qualitative and semiquantitative analysis of amphetamines in human urine."
- Performance Studies: The document describes performance studies comparing the device's results with a reference method (GC/MS) using human urine specimens. This is typical for IVD devices undergoing regulatory review.
- Predicate Device: The mention of a "Predicate Device" (K993982; Syva® Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay) is also a strong indicator that this device is being compared to a previously cleared IVD.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition, or for the assessment of the health of a human being. This device fits that description by analyzing human urine for the presence of amphetamines.
N/A
Intended Use / Indications for Use
The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
The Emit® II Plus Amphetamines 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 spectrometry (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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ
Device Description
The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay for the qualitative and semiquantitative analysis of amphetamines in human urine.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison - Qualitative (300 ng/mL Cutoff):
- The results of one hundred and twenty-four (124) urine specimens obtained with the Syva® Emit® II Plus Amphetamines Assay on the Syva®-30R Biochemical System (K912024) were compared to the results obtained with the reference method, GC/MS. Both methods used a cutoff level of 300 ng/mL for total amphetamines.
- Sixty-two (62) out of sixty-six (66) samples found positive by GC/MS (≥ 300 ng/mL total amphetamines) were also found positive by Syva Emit II Plus Amphetamines Assay.
- Fifty-eight (58) samples were found negative by GC/MS (500 ng/mL total amphetamines) but considered negative by GC/MS because they did not meet the 100 ng/mL amphetamine criterion for SAMHSA confirmatory test. One (1) discrepant sample was identified as negative by the proposed device and had total amphetamines within -25% of the cutoff level semiquantitatively.
Method Comparison - Qualitative (1000 ng/mL Cutoff):
- The results of one hundred and twenty-four (124) urine specimens obtained with the Syva® Emit® II Plus Amphetamines Assay on the Syva®-30R Biochemical System (K912024) were compared to GC/MS as reference methodology. The proposed method used a cutoff level of 1000 ng/mL while the reference method used a cutoff level of 500 ng/mL according to SAMHSA confirmatory guideline (amphetamine 500 ng/mL or methamphetamine 500 ng/mL plus minimum amphetamine 200 ng/mL).
- Fifty-five (55) out of sixty-five (65) samples found positive by GC/MS (SAMHSA confirmatory guidelines) were also found positive (≥1000 ng/mL) by Syva® Emit® II Plus Amphetamines Assay.
- Fifty-two (52) out of fifty-nine (59) samples found negative by GC/MS were also found negative by the proposed device.
- Seventeen (17) discrepant samples were found. Seven (7) of these were positive by the proposed device (with semiquantitative results >1000 ng/mL) but considered negative by GC/MC due to not meeting the minimum 200 ng/mL amphetamine criterion for SAMHSA confirmatory test. Ten (10) discrepant samples were found negative by the proposed test and had total amphetamines values within -25% and the cutoff.
Comparative Method (1000 ng/mL Cutoff):
- The Syva® Emit® II Plus Amphetamines Assay was compared to the Syva® Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay (K993982) using the same number of urine specimens on the Syva®-30R Biochemical System. Both devices used a cutoff level of 1000 ng/mL for total amphetamines.
- Fifty-nine (59) out of sixty (60) samples found positive by the comparative method were also found positive (≥1000 ng/mL) by Syva® Emit® II Plus Amphetamines Assay.
- Sixty-one (61) out of sixty-four (64) samples found negative by the comparative method were also found negative by the proposed device.
- Four discrepant samples were found. Three (3) of these were positive by the proposed device and confirmed positive by GC/MS. One (1) discrepant sample found negative by the proposed device was also confirmed negative by GC/MS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Qualitative Results 300 ng/mL Cutoff:
- Percent agreement: 97%
Qualitative Results 500 ng/mL Cutoff:
- Percent agreement: 96%
Qualitative Results 1000 ng/mL Cutoff (GC/MS comparison):
- Percent agreement: 86%
Qualitative Results 1000 ng/mL Cutoff (Comparative method):
- Percent agreement: 97%
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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).
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Dade Behring Inc. 510(k) Premarket Notification Syva® Emit® II Plus Amphetamines Assay
510(k) Summary of Safety and Effectiveness Information Syva® Emit® II Plus Amphetamines Assay March 28, 2003
MANUFACTURER AND CONTACT INFORMATION I.
Manufacturer: Syva Company - Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014
Contact Information: Dade Behring Inc. 500 GBC Drive Newark, DE 19702 Attn: Radames Riesgo Phone: 305.480.7558 FAX: 305.552.5288
II. DEVICE NAME AND CLASSIFICATION NAME
Trade or Proprietary Name: Syva® Emit® II Plus Amphetamines Assay
Common or Usual Name: Enzyme Immunoassay, Amphetamine/Methamphetamine Amphetamine test system (21 CFR §862.3100) Methamphetamine test system (21 CFR §862.3610) Class II
IDENTIFICATION OF THE LEGALLY MARKETED DEVICE III.
Syva® Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay (K993982).
DEVICE DESCRIPTION IV.
The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay for the qualitative and semiquantitative analysis of amphetamines in human urine.
V. DEVICE INTENDED USE
The Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff, 500 ng/mL cutoff or a 1000 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of amphetamines in human urine. Emit® II Plus assays are designed for use with a number of chemistry analyzers.
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1
The Emit® II Plus Amphetamines 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. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
VI. SUBSTANTIAL EQIVALENCE
The Emit® II Plus Amphetamines Assay is substantially equivalent in intended use and methodology to the Emit® II Plus Monoclonal Amphetamine/Methamphetamine Assay currently in the market. The proposed device, like the predicate device is a monoclonal antibody assay intended for the qualitative and semiquantitative analysis of amphetamines in human urine.
VII. DEVICE PERFORMANCE CHARACTERISTICS
300 ng/mL Cutoff A.
Method Comparison - Qualitative
The results of one hundred and twenty-four (124) urine specimens obtained with the Syva® Emit® II Plus Amphetamines Assay on the Syva®-30R Biochemical System (K912024) were compared to the results obtained with the reference method, GC/MS. Both methods used a cutoff level of 300 ng/mL for total amphetamines.
Of the sixty-six (66) samples found to be positive by GC/MS (≥ 300 ng/mL total amphetamines), sixty-two (62) were also found positive by Syva Emit II Plus Amphetamines Assay for a percent agreement of 97% (120/124). Fifty-eight (58) samples were found to be negative by GC/MS (