(68 days)
TDx N-acetylprocainamide, Enzyme Immunoassay N-acetylprocainamide
No
The device description details a biochemical immunoassay based on enzyme activity and antibody binding, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies focus on standard analytical characteristics like precision, linearity, and method comparison, not AI/ML model performance metrics.
No
Explanation: This device is an in vitro diagnostic immunoassay used to quantify N-acetylprocainamide in human samples, which aids in diagnosis and monitoring, rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the device is for the "in vitro quantitative determination of N-acetylprocainamide in human serum and plasma," which is a measurement used to aid in diagnosis or monitor drug levels. The device also has "Performance Characteristics" and "Key Metrics" that include specificity, all of which are common for diagnostic devices.
No
The device is an immunoassay, which is a laboratory test that uses antibodies to detect and measure substances. This involves physical reagents and a spectrophotometer for measurement, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The assay is performed on human serum and plasma, which are biological samples taken from the body but tested outside of it.
- Measurement: The device performs a "quantitative determination," meaning it measures the amount of a substance in the sample.
- Device Description: The description details a laboratory-based assay using enzymatic reactions and spectrophotometric measurement, typical of IVD tests.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The CEDIA® N-acetylprocainamide Assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, N-acetylprocainamide in the sample competes with analyte conjugated to one inactive frayment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics were reported for Precision, Lower Detection Limit, Linearity, Method Comparison, Interfering substances, and Specificity.
Precision:
CEDIA® N-acetylprocainamide:
Level 1 (1.91 µg/mL): N=120, Within run mean %CV = 5.84, Total mean %CV = 7.35
Level 2 (4.41 µg/mL): N=120, Within run mean %CV = 3.35, Total mean %CV = 4.08
Level 3 (10.75 µg/mL): N = 120, Within run mean %CV = 2.29, Total mean %CV = 2.87
TDx N-acetylprocainamide:
Low (4.06 µg/mL): N=120, %CV = 3.3 (within run), %CV = 3.1 (total)
Mid (9.18 µg/mL): N=120, %CV = 1.7 (within run), %CV = 2.4 (total)
High (23.80 µg/mL): N=120, %CV = 2.3 (within run), %CV = 5.5 (total)
Lower Detection Limit: 0.6 µg/dL for both CEDIA® and TDx N-acetylprocainamide.
Linearity: 0.6 - 30 µg/dL for CEDIA®, 0.0 - 30.0 µg/dL for TDx.
Method Comparison (CEDIA® vs Abbott TDx N-acetylprocainamide):
Least Squares: y = 1.04x + 0.21, r=0.994, N=125
Deming's: y=1.04x + 0.18, r=0.9940, N=125
Method Comparison (TDx vs Enzyme Immunoassay N-acetylprocainamide): y = 1.06x - 0.60, r=0.986, N=96
Interfering Substances (No interference at ±10% of error):
CEDIA® N-acetylprocainamide: Bilirubin 66 mg/dL, Hemoglobin 1000 mg/dL, Lipemia 1200 mg/dL, Total Protein 13 g/dL, Rheumatoid Factor 85 IU/mL.
TDx N-acetylprocainamide: Bilirubin 15 mg/dL, Hemoglobin 1000 mg/dL, Lipemia 1200 mg/dL, Total Protein 9.5 mg/dL. Rheumatoid Factor N/A.
Specificity (% Cross-reactivity):
CEDIA® N-acetylprocainamide: Procainamide 0.1, Desethyl-N-Acetyl-procainamide 21.7, Desethyl-procainamide 0.1.
TDx N-acetylprocainamide: Procainamide None detected, Desethyl-N-Acetyl-procainamide 18.2, Desethyl-procainamide Not tested.
Key Metrics (Sensitivity, Specificity, PPV,
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
OCT 2 9 1996
17:58
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. Boehringer Mannheim Corporation Submitter 2400 Bisso Lane name, address, P.O. Box 4117 contact Concord, CA 94524-4117 (510) 674 - 0690, extension 8240 Contact Person: Betsy Soares-Maddox Date Prepared: October 10, 1996 2. Proprietary name: CEDIA® N-acetylprocainamide Assay Device name Common name: Homogeneous enzyme immunoassay for the determination of N-acetylprocainamide. Classification name: Enzyme immunoassay, N-acety|procainamide 3. The Boehringer Mannheim CEDIA® N-acetylprocainamide is substantially Predicate equivalent to other products in commercial distribution intended for similar device use. Most notably it is substantially equivalent to the currently marketed Abbott TDx® N-acety|procainamide Assay (K830206).
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1
510(k) Summary, Continued
- Device Description The CEDIA® N-acetylprocainamide Assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, N-acetylprocainamide in the sample competes with analyte conjugated to one inactive frayment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
Continued on next page
2
510(k) Summary, Continued
| 5.
| Intended use | Immunoassay for the in vitro quantitative determination of N-acetylprocainamide in human serum and plasma. |
|---|---|
| 6. | |
| Comparison to | |
| predicate | |
| device | The Boehringer Mannheim CEDIA® N-acetylprocainamide Assay is |
| substantially equivalent to other products in commercial distribution intendedfor similar use. Most notably it is substantially equivalent to the currently | |
| marketed Abbott TDx® N-acetylprocainamide Assay (K830206). | |
| The following table compares the CEDIA® N-acetylprocainamide Assay | |
| with the predicate device, Abbott TDx® N-acetylprocainamide 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: | |
| •Intended Use: Immunoassay for the in vitro quantitative determination | |
| of N-acetylprocainamide | |
| • Sample type: Serum and plasma | |
| •Assay range: 0.6 - 30 µg/mL |
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29 -
3
510(k) Summary, Continued
Differences:
Comparison to
predicate
device cont.
| Feature | CEDIA®
N-acetylprocainamide | TDx
N-acetylprocainamide |
|----------------------------|--------------------------------|-----------------------------|
| Reaction test
principle | Spectrophotometric
570 nm | Fluorescence Polarization |
| Instrument
required | Hitachi 911 | Abbott TDx |
Performance Characteristics:
| Feature | CEDIA®
N-acetylprocainamide | | | TDx
N-acetylprocainamide | | |
|-----------------|--------------------------------|---------|---------|-----------------------------|------|-------|
| Precision | Modified NCCLS (µg/mL): | | | NCCLS (µg/mL): | | |
| Level | Level 1 | Level 2 | Level 3 | Low | Mid | High |
| N | 120 | 120 | 120 | 120 | 120 | 120 |
| Within run mean | 1.91 | 4.41 | 10.75 | 4.06 | 9.18 | 23.80 |
| %CV | 5.84 | 3.35 | 2.29 | 3.3 | 1.7 | 2.3 |
| Total mean | 1.91 | 4.41 | 10.75 | 4.06 | 9.18 | 23.80 |
| %CV | 7.35 | 4.08 | 2.87 | 3.1 | 2.4 | 5.5 |
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an-
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18:00
8510 674 5020
510(k) Summary, Continued
Performance Characteristics:
Comparison to
predicate
device, (cont.)
| Feature | CEDIA®
N-acetylprocainamide | TDx
N-acetylprocainamide |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Lower
Detection
Limit | 0.6 µg/dL | 0.6 µg/dL |
| Linearity | 0.6 - 30 µg/dL | 0.0 - 30.0 µg/dL |
| Method
Comparison | Vs Abbott TDx
N-acetylprocainamide
Least Squares
y =1.04x + 0.21
r=0.994
N=125
Deming's:
y=1.04x + 0.18
r=0.9940
N=125 | Vs Enzyme Immunoassay
N-acetylprocainamide
y =1.06x - 0.60
r=0.986
N=96 |
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18:00
なら…♡ っても もうとい
510(k) Summary, Continued
Performance Characteristics:
Comparison to
predicate
device, (cont.)
| Feature | CEDIA®
N-acetylprocainamide | TDx
N-acetylprocainamide |
|----------------------------------------|----------------------------------------|-----------------------------|
| Interfering
substances | No interference at:
(±10% of error) | No interference at: |
| Bilirubin | 66 mg/dL | 15 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Lipemia | 1200 mg/dL | 1200 mg/dL |
| Total Protein | 13 g/dL | 9.5 mg/dL |
| Rheumatoid
Factor | 85 IU/mL | N/A |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| Procainamide | 0.1 | None detected |
| Desethyl-N-
Acetyl-
procainamide | 21.7 | 18.2 |
| Desethyl-
procainamide | 0.1 | Not tested |