(148 days)
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No
The device description details a standard enzyme immunoassay based on competitive binding and enzymatic reactions. There is no mention of AI, ML, or any computational learning processes. The performance studies describe standard analytical validation metrics for an immunoassay.
No
This device is an in-vitro diagnostic assay used for qualitative and semi-quantitative measurement of benzodiazepines in human urine, aiding in diagnosis and treatment monitoring, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements are used as an aid in the diagnosis and treatment of benzodiazepine use or overdose." This indicates its role in the diagnostic process.
No
The device description clearly outlines a chemical assay involving reagents, enzymes, and competitive binding, indicating a hardware-based in-vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the assay is for the qualitative and semi-quantitative assay of benzodiazepines in human urine. It also mentions that the measurements are used as an aid in the diagnosis and treatment of benzodiazepine use or overdose. This clearly indicates that the device is intended to be used in vitro (outside the body) to examine a human specimen (urine) for diagnostic purposes.
- Device Description: The description details a "homogeneous enzyme immunoassay" that is used for the "in-vitro enzyme immunoassay" of benzodiazepines in urine. This further confirms its in vitro nature.
- Anatomical Site: The specified "Anatomical Site" is "human urine," which is a human specimen analyzed in vitro.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified CEDIA DAU Benzodiazepine Assay is a homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of benzodiazepines in human urine. Measurements are used as an aid in the diagnosis and treatment of benzodiazepine use or overdose.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The modified CEDIA® DAU Benzodiazepine Assay is an in-vitro enzyme immunoassay used for the qualitative and homogeneous semi-quantitative measurement of benzodiazepines in urine. It is based on competitive binding concepts employing benzodiazepine derivative labeled (ß-galactosidase) competing with sample enzymatic fragments benzodiazepines for the benzodiazepine-specific antibody. Using recombinant DNA techniques, the B-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. A benzodiazepine derivative has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to vield active B-galactosidase enzyme. Benzodiazepine-specific antibody, by binding to the benzodiazepine derivative on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of B-galactosidase formed. The amount of enzyme formed is proportional to the amount of benzodiazepines as monitored by the hydrolysis of the substrate chlorophenol red-B-D-galactopyranoside (CPRG). The optional b-Glucuronidase reagent, when added to the Enzyme Acceptor reagent and mixed with sample on the analyzer, hydrolyzes glucuronide metaboliotes of benzodiazepines, thereby increasing the recognition of samples containing benzodiazepine metabolites.
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)
Performance Characteristics: (note: data generated from modified CEDIA DAU Benzodiazepine assay used the ß-Glucuronidase application.)
Precision:
Modified NCCLS (mA/min): 200 ng/mL Cutoff Protocol
Concentration Level: 150, 200, 250
N: 120 for each concentration level
Within-Run: 303.0 (150 ng/mL), 331.7 (200 ng/mL), 363.1 (250 ng/mL)
%CV Within-Run: 0.8 (150 ng/mL), 0.8 (200 ng/mL), 0.9 (250 ng/mL)
Total: 303.0 (150 ng/mL), 331.7 (200 ng/mL), 363.1 (250 ng/mL)
%CV Total: 5.9 (150 ng/mL), 6.0 (200 ng/mL), 5.8 (250 ng/mL)
Sensitivity (LOD) 200 ng/mL Cutoff: 12.3 ng/mL
Sensitivity (LOQ) 200 ng/mL Cutoff: 12.1 ng/mL
Accuracy 200 ng/mL Cutoff Sensitivity: Vs. CEDIA Benzodiazepine Assay 100.0%
Specificity: 95.1%
Interfering substances: Less than 10% error at:
Acetone: 1 g/dL
Ascorbic Acid: 0.15 g/dL
Creatinine: 0.5 g/dL
Ethanol: 1 g/dL
Galactose: 10 mg/dL
γ-globulin: 0.5 g/dL
Glucose: 3 g/dL
Hemoglobin: 0.3 g/dL
Human Serum Albumin: 0.5 g/L
Oxalic Acid: 0.1g/dL
Riboflavin: 7.5 mg/dL
Sodium Chloride: 6 g/dL
Urea: 4 g/dL
Specificity: Multiple benzodiazepine compounds
Key results from comparison to predicate device:
- Both Assays use the same kit.
- Both assays are used on the BM/Hitachi 717 analyzer using the same chemistry parameters.
- Both assays are for qualitative and semiquantitative determination of benzodiazepines in urine.
- Differences: Addition of B-Glucuronidase to the reconstituted Enzyme Acceptor reagent. Higher sensitivity to conjugated benzodiazepine compounds. When B-Glucuronidase is utilized, only the 200 ng/mL cutoff is available.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (LOD) 200 ng/mL Cutoff: 12.3 ng/mL
Sensitivity (LOQ) 200 ng/mL Cutoff: 12.1 ng/mL
Accuracy 200 ng/mL Cutoff Sensitivity: Vs. CEDIA Benzodiazepine Assay 100.0%
Specificity: 95.1%
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K9627354
DEC 1 0 1996
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Diagnostics
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation |
| 2400 Bisso Lane | |
| Concord, CA 94524 | |
| (510) 674-0667 | |
| Contact Person: Betsy Soares-Maddox | |
| Date Prepared: July 11, 1996 | |
| 2) Device name | Proprietary name: CEDIA DAU Benzodiazepine Assay |
| Common name: Homonogeneous enzyme immunoassay for the determination of benzodiazepine levels in urine. | |
| Classification name: Benzodiazepine test system | |
| 3) Predicate device | We claim substantial equivalence to the CEDIA DAU Benzodiazepine Assay (K954626) |
Continued on next page
1
4) Device The modified CEDIA® DAU Benzodiazepine Assay is an in-vitro Description enzyme immunoassay used for the qualitative and homogeneous semiquantitative measurement of benzodiazepines in urine. It is based on competitive binding concepts employing benzodiazepine derivative labeled (ß-galactosidase) competing with sample enzymatic fragments benzodiazepines for the benzodiazepine-specific antibody. Using recombinant DNA techniques, the B-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. A benzodiazepine derivative has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to vield active B-galactosidase enzyme. Benzodiazepine-specific antibody, by binding to the benzodiazepine derivative on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of B-galactosidase formed. The amount of enzyme formed is proportional to the amount of benzodiazepines as monitored by the hydrolysis of the substrate chlorophenol red-B-D-galactopyranoside (CPRG). The optional b-Glucuronidase reagent, when added to the Enzyme Acceptor reagent and mixed with sample on the analyzer, hydrolyzes glucuronide metaboliotes of benzodiazepines, thereby increasing the recognition of samples containing benzodiazepine metabolites.
- Intended u se
The Modified CEDIA DAU Benzodiazepine Assay is a homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of benzodiazepines in human urine. Measurements are used as an aid in the diagnosis and treatment of benzodiazepine use or overdose.
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2
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Q) Comparison to predicate device
The Boehringer Mannheim modified CEDIA DAU Benzodiazepine Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Boehringer Mannheim CEDIA DAU Benzodiazepine Assay (K954626).
The following table compares the modified CEDIA DAU Benzodiazepine Assay with the predicate device, CEDIA DAU Benzodiazepine Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.
Similarities:
- · Both Assays use the same kit
· Both assays are used on the BM/Hitachi 717 analyzer using the same chemistry parameters
· Both assays are for qualitative and semiquantitative determination of benzodiazepines in urine.
Differences:
· Addition of B-Glucuronidase to the reconstituted Enzyme Acceptor reagent. (This component is sold separately.)
- · Higher sensitivity to conjugated benzodiazepine compounds
- · When B-Glucuronidase is utilized, only the 200 ng/mL cutoff is available.
Continued on next page
3
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Comparison to predicate device, (cont.) Performance Characteristics: (note: data generated from modified CEDIA DAU Benzodiazepine assay used the ß-Glucuronidase application.)
| Feature | Modified CEDIA DAU
Benzodiazepine | | | CEDIA DAU
Benzodiazepine | | |
|---------------------------------------------|----------------------------------------------------------|-------|-------|----------------------------------------------------------|-------|-------|
| Precision | Modified NCCLS
(mA/min):
200 ng/mL Cutoff Protocol | | | Modified NCCLS
(mA/min):
200 ng/mL Cutoff Protocol | | |
| Concentration
Level | 150 | 200 | 250 | 150 | 200 | 250 |
| N | 120 | 120 | 120 | 120 | 120 | 120 |
| Within-Run | 303.0 | 331.7 | 363.1 | 299.6 | 324.3 | 362.1 |
| %CV | 0.8 | 0.8 | 0.9 | 0.9 | 0.8 | 0.9 |
| Total | 303.0 | 331.7 | 363.1 | 299.6 | 324.3 | 362.1 |
| %CV | 5.9 | 6.0 | 5.8 | 3.5 | 3.5 | 3.5 |
| Sensitivity (LOD)
200 ng/mL Cutoff | 12.3 ng/mL | | | 10.8 ng/mL | | |
| Sensitivity (LOQ)
200 ng/mL Cutoff | 12.1 ng/mL | | | 10.7 ng/mL | | |
| Accuracy
200 ng/mL Cutoff
Sensitivity | Vs. CEDIA Benzodiazepine
Assay
100.0% | | | Vs. EMIT II
Benzodiazepine Assay
98.2% | | |
| Specificity | 95.1% | | | 99.1% | | |
Continued on next page
)
4
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Comparison
to predicate
device (cont.)
| Feature | Modified CEDIA DAU
Benzodiazepine | CEDIA DAU
Benzodiazepine |
|---------------------------|--------------------------------------|--------------------------------------|
| Interfering
substances | Less than 10% error at: | Less than 10% error at: |
| Acetone | 1 g/dL | 1 g/dL |
| Ascorbic Acid | 0.15 g/dL | 0.15 g/dL |
| Creatinine | 0.5 g/dL | 0.5 g/dL |
| Ethanol | 1 g/dL | 1 g/dL |
| Galactose | 10 mg/dL | 10 mg/dL |
| y-globulin | 0.5 g/dL | 0.3 g/dL |
| Glucose | 3 g/dL | 1.5 g/dL |
| Hemoglobin | 0.3 g/dL | 0.3 g/dL |
| Human Serum
Albumin | 0.5 g/L | 0.5 g/L |
| Oxalic Acid | 0.1g/dL | 0.1g/dL |
| Riboflavin | 7.5 mg/dL | 7.5 mg/dL |
| Sodium Chloride | 6 g/dL | 6 g/dL |
| Urea | 4 g/dL | 6 g/dL |
| Specificity | Multiple benzodiazepine
compounds | Multiple benzodiazepine
compounds |