(15 days)
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No
The device is a quality control material for a laboratory assay and the description focuses on its composition, storage, and performance characteristics (stability, precision) as a control. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML.
No
This device is a control used for monitoring the quality control of cannabinoid (THC) testing in a clinical laboratory; it is not intended to treat or diagnose.
No
This device is described as a control for monitoring the quality of cannabinoid (THC) testing in a clinical laboratory. It is used to ensure proper assay performance, rather than to diagnose a condition in a patient.
No
The device is a liquid control solution intended for use in laboratory testing, not a software program.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the quality control of cannabinoid (THC) testing in the clinical laboratory." This is a classic function of an IVD, which are used to examine specimens from the human body to provide information for diagnostic purposes. While these controls aren't directly diagnosing a patient, they are essential for ensuring the accuracy and reliability of the diagnostic test (the THC assay).
- Device Description: It's described as "ready-to-use, human urine based liquid controls." This indicates it's a reagent or material used in vitro (outside the body) to analyze a human specimen (urine).
- Predicate Device: The mention of a predicate device (K932113; 4 Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (DRI)) which is also a control material for cannabinoid testing, further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is where IVD testing is performed.
While the device itself isn't performing the diagnostic test, it is a critical component of the overall in vitro diagnostic process for THC testing. It ensures the accuracy of the results obtained from the diagnostic reagent and analyzer.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems 10 ng/mL and 40 ng/mL THC Urine Controls, in conjunction with the SYNCHRON Cannabinoid 20 ng (THC2) Reagent, are intended for use on SYNCHRON Systems for monitoring the quality control of cannabinoid (THC) testing in the clinical laboratory. These controls are 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, CX7 DELTA Systems and LX™20 Systems.
Product codes
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Device Description
The SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls, are ready-to-use, human urine based liquid controls designed to be used as part of a laboratory total quality management program to ensure proper THC assay performance. These controls complement the current panel of Cannabinoid reagents and controls previously SYNCHRON® Systems cleared by the FDA. The kit consists of 1 x 5.0 mL bottle and must be stored at +2°C to + 8°C.
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
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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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to a control test system already in commercial distribution. Equivalence is demonstrated through stability and imprecision studies that relate results obtained from the SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls to the DRI Cannabinoid Urine Controls.
Stability Study Results:
Product Claim: 24 month shelf-life
Precision Study Results:
Material: Negative Calibrator, Mean (mA/min): 262.40, SD (mA/min): 0.95, %CV: 0.36, Number of Results: 20
Material: THC Control 1 (10 ng/mL), Mean (mA/min): 272.36, SD (mA/min): 1.45, %CV: 0.53, Number of Results: 20
Material: Low Calibrator (20 ng/mL), Mean (mA/min): 283.32, SD (mA/min): 1.30, %CV: 0.46, Number of Results: 20
Material: THC Control 2 (40 ng/mL), Mean (mA/min): 306.98, SD (mA/min): 1.52, %CV: 0.49, Number of Results: 20
Material: High Calibrator (50 ng/mL), Mean (mA/min): 319.38, SD (mA/min): 1.32, %CV: 0.41, Number of Results: 20
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.
0
APR 1 7 1997
Summary of Safety & Effectiveness SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls
1.0 Submitted By:
سمب «"
Frank Marte, R.A.C. Regulatory Affairs Staff Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-4406 FAX: (714) 961-4457
2.0 Date Submitted:
31 March 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems 10 ng/mL THC Urine Control SYNCHRON® Systems 40 ng/mL THC Urine Control
3.2 Classification Names
Clinical Toxicology Control Material (21 CFR § 862.3280)
Predicate Device(s): 4.0
4 Cannabinoid Urine Controls, Diagnostic Reagents, Inc. (DRI), K932113
5.0 Description:
The SYNCHRON® Systems 10 ng/mL and 40ng/mL THC Urine Controls, are ready-to-use, human urine based liquid controls designed to be used as part of a laboratory total quality management program to ensure proper THC assay performance. These controls complement the current panel of
1
Cannabinoid reagents and controls previously SYNCHRON® Systems cleared by the FDA. The kit consists of 1 x 5.0 mL bottle and must be stored at +2°C to + 8°C.
6.0 Intended Use:
The SYNCHRON Systems 10 ng/mL and 40 ng/mL THC Urine Controls, in conjunction with the SYNCHRON Cannabinoid 20 ng (THC2) Reagent, are intended for use on SYNCHRON Systems for monitoring the quality control of cannabinoid (THC) testing in the clinical laboratory. These controls are 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, CX7 DELTA Systems and LX™20 Systems.
E
2
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| SYNCHRON | ||
| Systems 10 and | ||
| 40 ng/mL THC | ||
| Urine Controls | Liquid, ready-to-use, human urine | |
| matrix control. | Same as DRI | |
| Intended use (for monitoring the | ||
| quality control of THC enzyme | ||
| immunoassays) | Same as DRI | |
| Manufacturing process and | ||
| qualification | Same as DRI | |
| DIFFERENCES | ||
| SYNCHRON | ||
| Systems 10 and | ||
| 40 ng/mL THC | ||
| Urine Controls | Labeling | Controls are labeled at |
| DRI using Beckman | ||
| labels and insert | ||
| Limitations for use | Controls are to be used | |
| only with SYNCHRON | ||
| Systems and | ||
| SYNCHRON | ||
| Cannabinoid 20 ng | ||
| (THC2) Reagent | ||
| Concentration of THC in the 10 | ||
| ng/mL control | The concentration level | |
| of THC in the lower | ||
| control is 10 ng/mL |
3
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to a control test system already in commercial distribution. Equivalence is demonstrated through stability and imprecision studies that relate results obtained from the SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls to the DRI മീ Cannabinoid Urine Controls.
Stability Study Results
| Reagent | Product Claim |
|---|---|
| SYNCHRON® Systems | |
| 10 ng/mL and 40ng/mL | |
| THC Urine Controls | 24 month shelf-life |
4
Precision Study Results
| Material | Mean (mA/min) | SD (mA/min) | %CV | Number of Results |
|---|---|---|---|---|
| Negative Calibrator | 262.40 | 0.95 | 0.36 | 20 |
| THC Control 1 (10 ng/mL) | 272.36 | 1.45 | 0.53 | 20 |
| Low Calibrator (20 ng/mL) | 283.32 | 1.30 | 0.46 | 20 |
| THC Control 2 (40 ng/mL) | 306.98 | 1.52 | 0.49 | 20 |
| High Calibrator (50 ng/mL) | 319.38 | 1.32 | 0.41 | 20 |
SYNCHRON® Systems 10 ng/mL and 40 ng/mL THC Urine Controls
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.