(91 days)
Not Found
No
The summary describes a chemical reagent-based assay for drug detection, with no mention of AI or ML technologies.
No
The device is a diagnostic tool used to detect the presence of Benzodiazepine in human urine. It is not designed to treat or prevent a disease or condition.
Yes
The device is described as "intended for the qualitative determination of Benzodiazepine (BNZG) in human urine," indicating its use in identifying a medical condition (presence of a substance) which is a diagnostic function. The "rapid screening procedure for determining the presence of the analyte in urine" further supports its role in diagnosis.
No
The device is a reagent used in conjunction with a hardware system (SYNCHRON® System(s)) for chemical analysis of urine. It is a chemical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative determination of Benzodiazepine (BNZG) in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of benzodiazepines).
- Device Description: The description further clarifies that it's a "rapid screening procedure for determining the presence of the analyte in urine." This reinforces its role in diagnosing or screening for the presence of a substance in a biological sample.
- Anatomical Site: The anatomical site is listed as "human urine," which is a biological specimen collected from the human body for analysis.
- Performance Studies: The document includes details about performance studies like method comparison and imprecision, which are standard for evaluating the performance of IVD devices.
- Key Metrics: The inclusion of metrics like Sensitivity, Specificity, and Overall Agreement are also typical for describing the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" with a K number (K023048) indicates that this device is being compared to a previously cleared IVD device, which is a common regulatory pathway for IVDs.
All of these factors strongly indicate that this device is intended for use as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
BNZG reagent, when used in conjunction with SYNCHRON® System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine (BNZG) in human urine at a cutoff value of 200 ng/mL (oxazepam).
Product codes
JXM
Device Description
The BNZG assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary analytical result, a positive result by these assays should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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
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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, linearity, and imprecision experiments.
Method Comparison (Concordance Summary with GC/MS as reference):
SYNCHRON CX BNZG (or SYNCHRON LX20 BNZG)
Sample size: 158
GC/MS POS: 95
GC/MS NEG: 63
SYNCHRON CX BNZG POS: 103 (93 true positives, 10 false positives)
SYNCHRON CX BNZG NEG: 55 (2 false negatives, 53 true negatives)
Sensitivity: 98%
Specificity: 84%
Overall Agreement: 92%
Imprecision Results (SYNCHRON CX System BNZG Reagent):
Within-Run Imprecision:
Urine Control 1: Mean Rate 408.95 mA/min, S.D. 2.129, %C.V. 0.5, N 80
Urine Control 2: Mean Rate 447.26 mA/min, S.D. 3.431, %C.V. 0.8, N 80
Urine Pool: Mean Rate 438.91 mA/min, S.D. 3.407, %C.V. 0.8, N 80
Total Imprecision:
Urine Control 1: Mean Rate 408.95 mA/min, S.D. 2.931, %C.V. 0.7, N 80
Urine Control 2: Mean Rate 447.26 mA/min, S.D. 4.258, %C.V. 1.0, N 80
Urine Pool: Mean Rate 438.91 mA/min, S.D. 3.883, %C.V. 0.9, N 80
Imprecision Results (SYNCHRON LX System BNZG Reagent):
Within-Run Imprecision:
Urine Control 1: Mean Rate 439.00 mA/min, S.D. 3.276, %C.V. 0.8, N 80
Urine Control 2: Mean Rate 480.04 mA/min, S.D. 4.631, %C.V. 1.0, N 80
Urine Pool: Mean Rate 470.16 mA/min, S.D. 4.133, %C.V. 0.9, N 80
Total Imprecision:
Urine Control 1: Mean Rate 439.00 mA/min, S.D. 4.524, %C.V. 1.0, N 80
Urine Control 2: Mean Rate 480.04 mA/min, S.D. 4.839, %C.V. 1.0, N 80
Urine Pool: Mean Rate 470.16 mA/min, S.D. 4.905, %C.V. 1.0, N 80
Key Metrics
Sensitivity: 98%
Specificity: 84%
Overall Agreement: 92%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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
MAR 2 8 2005
510(k) Summary SYNCHRON® Systems BNZG Reagent
1.0 Submitted By:
Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123
2.0 Date Submitted:
December 22, 2004
3.0 Device Name(s):
Proprietary Names 3.1
SYNCHRON® Systems Benzodiazepines (BNZG) Reagent
3.2 Classification Name
Benzodiazepine test system [21 CFR § 862.3170]
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|----------------------------------|----------------------------------|--------------------------|------------------|
| SYNCHRON Systems
BNZG Reagent | SYNCHRON Systems
BENZ Reagent | Beckman Coulter,
Inc. | K023048 |
5.0 Description:
The BNZG assay provides a rapid screening procedure for determining the presence of the analyte in urine. This test provides only a preliminary analytical result, a positive result by these assays should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
6.0 Intended Use:
BNZG reagent, when used in conjunction with SYNCHRON® System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine (BNZG) in human urine at a cutoff value of 200 ng/mL (oxazepam).
1
The BNZG assay provides a rapid screening procedure for determining the presence of The BNZS assay provides only a preliminary analytical result, a positive result by these assays should be confirmed by another generally accepted non-immunological method such as thin layer chromatography (TLC), gas chromatography (GC), or gas method such as thir layer onliners (GC/MS). GC/MS is the preferred confirmatory method.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Clinical Significance:
Benzodiazepines are a class of central nervous system depressants that are used as Denzodiazepines are a class of contractiazepine compounds include chlordiazepoxide, Sedatives and Tryphotos. - The benz ditazepam. Measurements of benzodiazepines on ulazepan, ഗ്രാമായ്, nuralespann, al in the diagnosis and treatment of benzodiazepine use the orrestines of of of of are presence of benzodiazepines to ensure appropriate therapy.
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| BNZG Reagent | Intended Use | |
| Liquid stable reagent | ||
| Stability | ||
| Calibrators | ||
| Controls | Same as BENZ | |
| Differences | ||
| BNZG Reagent | Cross reactivity | Different due to new antibody and |
| glucuronidase enzyme | ||
| Reagent volume | 260 µL for BNZG due to enzyme | |
| 250 µL for BENZ |
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, linearity, and imprecision experiments.
| SYNCHRON CX BNZG | ||||||
|---|---|---|---|---|---|---|
| POS | NEG | TOTAL | ||||
| GC/MS | POS | 93 | 2 | 95 | Sensitivity | 98% |
| NEG | 10 | 53 | 63 | Specificity | 84% | |
| TOTAL | 103 | 55 | 158 | Overall | ||
| Agreement | 92% |
BNZG Concordance Summary
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BNZG Concordance Summary SYNCHRON LX Systems
| SYNCHRON LX20 BNZG | ||||||
|---|---|---|---|---|---|---|
| POS | NEG | TOTAL | Sensitivity | 98% | ||
| GC/MS | POS | 93 | 2 | 95 | Specificity | 84% |
| NEG | 10 | 53 | 63 | Overall | ||
| Agreement | 92% | |||||
| TOTAL | 103 | 55 | 158 |
SYNCHRON CX System BNZG Reagent Imprecision Results
| Sample | Mean
Rate
(mA/min) | S.D. | %C.V. | N |
|------------------------|--------------------------|-------|-------|----|
| Within-Run Imprecision | | | | |
| Urine Control 1 | 408.95 | 2.129 | 0.5 | 80 |
| Urine Control 2 | 447.26 | 3.431 | 0.8 | 80 |
| Urine Pool | 438.91 | 3.407 | 0.8 | 80 |
| Total Imprecision | | | | |
| Urine Control 1 | 408.95 | 2.931 | 0.7 | 80 |
| Urine Control 2 | 447.26 | 4.258 | 1.0 | 80 |
| Urine Pool | 438.91 | 3.883 | 0.9 | 80 |
SYNCHRON LX System BNZG Reagent Imprecision Results
| Sample | Mean
Rate
(mA/min) | S.D. | %C.V. | N |
|------------------------|--------------------------|-------|-------|----|
| Within-Run Imprecision | | | | |
| Urine Control 1 | 439.00 | 3.276 | 0.8 | 80 |
| Urine Control 2 | 480.04 | 4.631 | 1.0 | 80 |
| Urine Pool | 470.16 | 4.133 | 0.9 | 80 |
| Total Imprecision | | | | |
| Urine Control 1 | 439.00 | 4.524 | 1.0 | 80 |
| Urine Control 2 | 480.04 | 4.839 | 1.0 | 80 |
| Urine Pool | 470.16 | 4.905 | 1.0 | 80 |
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.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized graphic of an abstract caduceus. The caduceus is depicted with three intertwined strands and a stylized wing at the top. The overall design is simple and monochromatic.
MAR 2 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. P.O. Box 8000 Brea, CA 92822-8000
Re: K043556
Trade/Device Name: SYNCHRON® Systems Benzodiazepines (BNZG) Reagent Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepines test system Regulatory Class: Class II Product Code: JXM Dated: March 4, 2005 Received: March 15, 2005
Dear Ms. Hellie:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure