(80 days)
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No
The summary describes a standard enzyme immunoassay reagent kit for a chemistry analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "reagent" for "qualitative determination of Methaqualone in human urine samples," indicating it is for diagnostic testing, not treatment.
Yes
The device is intended for the "qualitative determination of Methaqualone in human urine samples," which clearly indicates its use in identifying a medical condition (presence of a substance) in a patient sample.
No
The device is described as a "reagent test kit" consisting of "reagent and calibrators," which are physical components, not software. It is intended for use with specific hardware analyzers (SYNCHRON Systems).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "qualitative determination of Methaqualone in human urine samples." This involves testing a sample taken from the human body (urine) outside of the body (in vitro) to provide diagnostic information (presence of Methaqualone).
- Device Description: The description refers to it as an "enzyme immunoassay reagent test kit" and a "rapid screening procedure for determining the presence of Methaqualone and it's metabolites in urine." This further confirms its use in laboratory testing of biological samples.
- Performance Studies: The performance studies compare the device's results to other diagnostic tests (Emit II Reagent and GCMS), which is typical for validating an IVD.
- Predicate Devices: The predicate devices listed are also diagnostic assays (Emit II Methaqualone Assay, Methaqualone Reagent, Urine Calibrator and Controls), indicating that this device falls into the same category.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX6 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
Product codes
DKF, JIX, JJE
Device Description
The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of Methaqualone 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
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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)
Equivalence to predicate devices is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the SYNCHRON Systems Methaqualone Reagent to the Emit II Reagent.
Comparison to Emit II:
- Overall Agreement: 94%
- Relative Sensitivity: 88%
- Relative Specificity: 100%
- Number of Disconcordant w/ Emit II: 6
- Number of Disconcordant w/ GCMS: 0
- Total Number of Samples: 103
Stability Study Results:
- Shelf-life: 12 months unopened
- On-Instrument Stability: 60 days
- Calibration Frequency: 7 days
Estimated Within-Run Imprecision:
- Negative Calibrator (Mean: 117 mA/min, SD: 0.8 mA/min, %CV: 0.6, Number of Results: 20)
- Control 1 (200 ng/mL) (Mean: 216 mA/min, SD: 1.1 mA/min, %CV: 0.5, Number of Results: 20)
- Low Calibrator (300 ng/mL) (Mean: 243 mA/min, SD: 0.9 mA/min, %CV: 0.4, Number of Results: 20)
- Control 2 (375 ng/mL) (Mean: 265 mA/min, SD: 1.0 mA/min, %CV: 0.4, Number of Results: 20)
- High Calibrator (1000 ng/mL) (Mean: 290 mA/min, SD: 0.9 mA/min, %CV: 0.3, Number of Results: 20)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 88%
Relative Specificity: 100%
Overall Agreement: 94%
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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§ 862.3630 Methaqualone test system.
(a)
Identification. A methaqualone test system is a device intended to measure methaqualone, a hypnotic and sedative drug, in urine. Measurements obtained by this device are used in the diagnosis and treatment of methaqualone use or overdose.(b)
Classification. Class II (special controls). A methaqualone 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
- 4 1996
Appendix C Summary of Safety & Effectiveness SYNCHRON® Systems Methaqualone Reagent
1.0 Submitted By
K 955676
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 Methaqualone (METQ) Reagent SYNCHRON Systems DAT Negative Urine Calibrator SYNCHRON Systems DAT Low Urine Calibrator II SYNCHRON Systems DAT High Urine Calibrator II SYNCHRON Systems DAT Low Urine Control II SYNCHRON Systems DAT High Urine Control II
3.2 Classification Names
Methaqualone test system (21 CFR 862.3630) Toxicology calibrator (21 CFR 862.3200) Toxicology control (21 CFR 862,3280)
4.0 Predicate Device(s)
Emit II Methaqualone Assay, Syva Company, K921013 Methaqualone Reagent, Diagnostic Reagents, Inc. K940123 Urine Calibrator and Controls, Diagnostic Reagents, Inc., K935101
5.0 Description
The SYNCHRON Methaqualone Reagent is an enzyme immunoassay reagent test kit for the SYNCHRON Systems and provides a rapid screening procedure for determining the presence of Methaqualone 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 Methaqualone Reagent, in conjunction with the SYNCHRON System DAT Urine Calibrators, is intended for use in the qualitative determination of
Beckman Instruments, Inc.
1wx. 910-592 1260 · The . 06-784 · 3
1
Methaqualone in human urine samples. This assay is designed for use with the family of SYNCHRON Systems, which include analyzers such as the SYNCHRON CX®4, CX6 DELTA, CX5, CX5CE, CX5 DELTA, CX7, and CX7 DELTA Systems.
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 Methaqualone Reagent | Emit II Methaqualone Reagent |
|---|---|
| Similarities | |
| Homogeneous enzyme immunoassay | |
| intended for the qualitative analysis of | |
| Methaqualone 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 companson, stability, and imprecision experiments that relate results obtained from the SYNCHRON Systems Methaqualone Reagent to the Emit II Reagent.
| Overall Agreement | 94% |
|---|---|
| Relative Sensitivity | 88% |
| Relative Specificity | 100% |
| Number of Disconcordant w/ Emit II | 6 |
| Number of Disconcordant w/ GCMS | 0 |
| Total Number of Samples | 103 |
Relative Sensitivity and Specificity Study Results CX Methaqualone Reagent vs Emit II
2
| Product Claim | 510(k) Summary |
|---|---|
| Shelf-life | 12 months unopened |
| On-Instrument Stability | 60 days |
| Calibration Frequency | 7 days |
SYNCHRON Methaqualone Stability Study Results
| Material | Mean
(mA/min) | SD
(mA/min) | %CV | Number of
Results |
|------------------------------|------------------|----------------|-----|----------------------|
| Negative Calibrator | 117 | 0.8 | 0.6 | 20 |
| Control 1 (200 ng/mL) | 216 | 1.1 | 0.5 | 20 |
| Low Calibrator (300 ng/mL) | 243 | 0.9 | 0.4 | 20 |
| Control 2 (375 ng/mL) | 265 | 1.0 | 0.4 | 20 |
| High Calibrator (1000 ng/mL) | 290 | 0.9 | 0.3 | 20 |
Estimated Within-Run Imprecision SYNCHRON Methaqualone 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.