(110 days)
No
The summary describes a standard enzyme immunoassay reagent kit for drug screening, with no mention of AI or ML in the intended use, device description, or performance studies. The analysis focuses on traditional analytical performance metrics like sensitivity and specificity.
No
The device is an in vitro diagnostic reagent kit used to detect the presence of cannabinoids in human urine samples, which is a diagnostic function, not a therapeutic one.
Yes
The device's intended use is for the "qualitative determination of cannabinoids in human urine samples," which is a diagnostic purpose to detect the presence of a substance.
No
The device is a reagent test kit, which is a physical component used in a laboratory setting, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative determination of cannabinoids in human urine samples." This involves testing a biological sample (urine) outside of the body (in vitro) to diagnose or screen for the presence of a substance (cannabinoids).
- Device Description: The description refers to it as an "enzyme immunoassay reagent test kit" and a "rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine." Immunoassays performed on biological samples are a common type of IVD.
- Predicate Devices: The predicate devices listed are also IVD assays for cannabinoids in urine. This further confirms the classification of this device as an IVD.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON® CX4, CX@4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
Product codes
Not Found
Device Description
The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the SYNCHRON Systems Cannabinoid 20 ng Reagent to the Emit II Reagent.
SYNCHRON Cannabinoid 20 ng Reagent vs Emit II
- Overall Agreement: 99%
- Relative Sensitivity: 99%
- Relative Specificity: 100%
- Number of Disconcordant w/ Emit II: 1
- Total Number of Samples: 136
SYNCHRON Cannabinoid 20 ng Reagent Stability Study Results
- Shelf-life: 12 months unopened
- On-Instrument Stability: 60 days
- Calibration Frequency: 7 days
Estimated Within-Run Imprecision SYNCHRON Cannabinoid 20 ng Reagent
- Negative Calibrator: Mean 245 (mA/min), SD 0.8 (mA/min), %CV 0.3, Number of Results 20
- Control 1 (0 ng/mL): Mean 245 (mA/min), SD 0.8 (mA/min), %CV 0.3, Number of Results 20
- Low Calibrator (20 ng/mL): Mean 274 (mA/min), SD 0.9 (mA/min), %CV 0.3, Number of Results 20
- Control 2 (50 ng/mL): Mean 318 (mA/min), SD 1.0 (mA/min), %CV 0.3, Number of Results 20
- High Calibrator (50 ng/mL): Mean 318 (mA/min), SD 1.1 (mA/min), %CV 0.3, Number of Results 20
Key Metrics
- Overall Agreement: 99%
- Relative Sensitivity: 99%
- Relative Specificity: 100%
Predicate Device(s)
Emit II Cannabinoid 20 ng Assay, Syva Company, K940158, Cannabinoid Reagent, Diagnostic Reagents, Inc. K943998, THC Urine Calibrators and Controls, Diagnostic Reagents, Inc., K944701
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
BECKMAN
Appendix C Summary of Safety & Effectiveness SYNCHRON® Systems Cannabinoid 20 ng Reagent
APR - 3
26
1.0 Submitted By
Sheri Hall Manager, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd. W-337 Brea, California 92621 Telephone: (714) 993-8916 FAX: (714) 961-4457
2.0 Date Submitted
15 December 1995
3.0 Device Name(s)
3.1 Proprietary Names
SYNCHRON Systems Cannabinoids 20 ng (THC2) Reagent SYNCHRON Systems DAT Negative Urine Calibrator SYNCHRON Systems 20 ng/mL THC Urine Calibrator SYNCHRON Systems 50 ng/mL THC Urine Calibrator SYNCHRON Systems 0 ng/mL THC Urine Control SYNCHRON Systems 50 ng/mL THC Urine Control
3.2 Classification Names
Cannabinoid test system (21 CFR 862.3870)
4.0 Predicate Device(s)
Emit II Cannabinoid 20 ng Assay, Syva Company, K940158 Cannabinoid Reagent, Diagnostic Reagents, Inc. K943998 THC Urine Calibrators and Controls, Diagnostic Reagents, Inc., K944701
5.0 Description
The SYNCHRON Cannabinoid 20 ng Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of cannabinoids and it's metabolites in urine. It is designed to complement the current panel of CX Drugs of Abuse Assays, previously cleared by FDA. The kit consists of reagent and calibrators.
6.0 Intended Use
The SYNCHRON Systems Cannabinoid 20 ng Reagent, in conjunction with the SYNCHRON Systems THC Urine Calibrators, is intended for use in the qualitative determination of cannabinoids in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON® CX4, CX@4CE, CX4 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
1
7.0 Comparison to Predicate(s)
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| SYNCHRON Cannabinoid Reagent | Emit II Cannabinoid Reagent |
|---|---|
| Similarities | |
| Homogeneous enzyme immunoassay | |
| intended for the qualitative analysis of | |
| cannabinoids in human urine | Same |
| Method based on competition between | |
| drug in the sample and drug labeled with | |
| the enzyme G6PDH; enzyme activity | |
| measured as NAD is converted to NADH | Same |
| Reagent designed for chemistry analyzers | |
| which maintain constant reaction | |
| temperature, use automated pipetting, | |
| measure enzyme rates, mix, and | |
| accurately time reactions | Same |
| Reagent provides preliminary analytical | |
| test for screening purposes | Same |
| Differences | |
| SYNCHRON reagent is liquid stabilized | |
| and requires no preparation | Emit II reagent is lyophilized and requires |
| reconstitution | |
| SYNCHRON reagent is intended for | |
| qualitative determinations only | Emit II reagent has a specialized |
| application for semi-quantitative | |
| determination of drug concentration | |
| SYNCHRON reagent is stable for 60 days | |
| once opened, when stored properly | Emit II reagent is stable for 12 weeks once |
| opened, if handled as directed |
8.0 Summary of Performance Data
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the SYNCHRON Systems Cannabinoid 20 ng Reagent to the Emit II Reagent.
| SYNCHRON Cannabinoid 20 ng Reagent vs Emit II | |
|---|---|
| Overall Agreement | 99% |
| Relative Sensitivity | 99% |
| Relative Specificity | 100% |
| Number of Disconcordant w/ Emit II | 1 |
| Total Number of Samples | 136 |
Relative Sensitivity and Specificity Study Results
SYNCHRON Cannabinoid 20 ng Reagent Stability Study Results
| Product Claim | 510(k) Summary |
|---|---|
| Shelf-life | 12 months unopened |
| On-Instrument Stability | 60 days |
| Calibration Frequency | 7 days |
2
| Material | Mean
(mA/min) | SD
(mA/min) | %CV | Number of
Results |
|----------------------------|------------------|----------------|-----|----------------------|
| Negative Calibrator | 245 | 0.8 | 0.3 | 20 |
| Control 1 (0 ng/mL) | 245 | 0.8 | 0.3 | 20 |
| Low Calibrator (20 ng/mL) | 274 | 0.9 | 0.3 | 20 |
| Control 2 (50 ng/mL) | 318 | 1.0 | 0.3 | 20 |
| High Calibrator (50 ng/mL) | 318 | 1.1 | 0.3 | 20 |
Estimated Within-Run Imprecision SYNCHRON Cannabinoid 20 ng Reagent
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.