(90 days)
Not Found
No
The device description details a biochemical immunoassay based on enzyme activity and competition for antibody binding. There is no mention of AI or ML in the description, performance studies, or key metrics. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is an immunoassay for the in vitro quantitative determination of procainamide, which is a diagnostic tool, not a therapeutic one.
Yes
The device is described as an "Immunoassay for the in vitro quantitative determination of procainamide in human serum and plasma," which directly indicates its use in determining the presence and quantity of a substance in a biological sample to aid in diagnosis or patient management.
No
The device description clearly outlines a chemical immunoassay based on enzyme activity and spectrophotometric measurement, indicating it is a laboratory diagnostic kit with physical reagents and a requirement for a spectrophotometer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "Immunoassay for the in vitro quantitative determination of procainamide 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.
- Method: The device uses an "Immunoassay," which is a common type of test performed in a laboratory setting to measure substances in biological fluids.
- Device Description: The description details a chemical reaction and spectrophotometric measurement, which are typical components of in vitro diagnostic tests.
All of these factors align 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 procainamide in human serum and plasma.
Product codes
Not Found
Device Description
The CEDIA® Procainamide Assay is based on the bacterial enzyme ßgalactosidase, 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, procainamide in the sample competes with analyte conjugated to one inactive fragment of ß-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)
Precision:
- CEDIA® Procainamide: Modified NCCLS (µg/mL)
- Level 1: N=120, Within-Run %CV=1.7, Total %CV=3.1
- Level 2: N=120, Within-Run %CV=1.7, Total %CV=3.0
- Level 3: N=120, Within-Run %CV=1.4, Total %CV=2.8
- TDx Procainamide: Modified NCCLS (µg/mL)
- Low: N=80, Within-Run %CV=2.5, Total %CV=5.4
- Mid: N=80, Within-Run %CV=1.9, Total %CV=4.2
- High: N=80, Within-Run %CV=2.2, Total %CV=4.6
Lower Detection Limit:
- CEDIA® Procainamide: 0.4 µg/dL
- TDx Procainamide: 0.1 µg/dL
Linearity:
- CEDIA® Procainamide: 0.4 - 20 µg/dL (with a deviation from a linear line of ±10%)
- TDx Procainamide: 0.0 - 20.0 µg/dL
Method Comparison:
- CEDIA® Procainamide Vs Abbott TDx Procainamide
- Least Squares: y = 1.04x + 0.03, r = 0.9914, SEE = 0.42, N = 122
- Deming's: y = 1.04x - 0.01, r = 0.9914, SEE = 0.30, N = 122
- TDx Procainamide Vs Enzyme Immunoassay Procainamide
- Least Squares: y = 1.01x - 0.18, r = 0.990, N = 262
Interfering substances:
- CEDIA® Procainamide: No interference at Bilirubin 66 mg/dL, Hemoglobin 1000 mg/dL, Lipemia 1000 mg/dL, Protein 6.5 g/dL Albumin, 10 g/dL IgG, Rheumatoid Factor 66 IU/ml
- TDx Procainamide: No interference at Bilirubin 15 mg/dL, Hemoglobin 1000 mg/dL, Lipemia 1200 mg/dL, Protein 9.5 mg/dL
Specificity (% Cross-reactivity):
- CEDIA® Procainamide: N-Acetyl-procainamide 1.0, Desethyl-N-Acetyl-procainamide 0.1, Desethyl procainamide 16.3, Procaine HCl 1.7
- TDx Procainamide: N-Acetyl-procainamide 1.0, Desethyl-N-Acetyl-procainamide None Detected, Desethyl procainamide 15
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for reported metrics including %CV, r, SEE, and % Cross-reactivity.
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.
Not Found
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
§ 862.3320 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
用站 27 1996
Image /page/0/Picture/1 description: The image shows the logo for Boehringer Mannheim Diagnostics. The logo consists of a black square with the words "mannheim boehringer" written in white inside a white circle. To the right of the logo is the text "K962099 Diagnostics" written in black.
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
P.O. Box 4117
Concord, CA 94524-4117
(510) 674 - 0690, extension 8415
Contact Person: Mary Koning
Date Prepared: May 24, 1996 |
| 2.
Device name | Proprietary name: CEDIA® Procainamide Assay
Common name: Homogeneous enzyme immunoassay for the determination of
procainamide.
Classification name: Enzyme immunoassay, procainamide |
| 3.
Predicate
device | The Boehringer Mannheim CEDIA® Procainamide is substantially equivalent
to other products in commercial distribution intended for similar use. Most
notably it is substantially equivalent to the currently marketed Abbott TDx®
Procainamide Assay (K834464). |
1
Image /page/1/Picture/0 description: The image shows the logo for Boehringer Mannheim Diagnostics. The logo consists of two parts: a square with the words "mannheim boehringer" arranged around a circle, and the word "Diagnostics" in a serif font. The word "Diagnostics" is to the right of the square.
- Device Description The CEDIA® Procainamide Assay is based on the bacterial enzyme ßgalactosidase, 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, procainamide in the sample competes with analyte conjugated to one inactive fragment of ß-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.
2
Image /page/2/Picture/0 description: The image shows the logo for Boehringer Mannheim Diagnostics. The logo consists of the words "mannheim boehringer" stacked on top of each other and enclosed in a black square with a white circle. To the right of the logo is the word "Diagnostics" in a serif font.
Immunoassay for the in vitro quantitative determination of procainamide in న. Intended use human serum and plasma. The Boehringer Mannheim CEDIA® Procainamide Assay is substantially 6. Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Abbott TDx® Procainamide Assay (K834464). The following table compares the CEDIA® Procainamide Assay with the predicate device. Abbott TDx® Procainamide 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 procainamide ·Sample type: Serum and plasma •Assay range: 0-420 µg/mL
3
Image /page/3/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the words "mannheim boehringer" in a black square with a white circle. To the right of the logo is the word "Diagnostics" in a serif font.
.
Comparison
to predicate device cont.
Differences:
| Feature | CEDIA® Procainamide | TDx Procainamide |
|---|---|---|
| Reaction test principle | Spectrophotometric | |
| 570 nm | Fluorescence Polarization | |
| Instrument required | Hitachi 911 | Abbott TDx |
Performance Characteristics:
| Feature | CEDIA® Procainamide | TDx Procainamide | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (µg/mL) | Modified NCCLS (µg/mL): | ||||
| Level | Level 1 | Level 2 | Level 3 | Low | Mid | High |
| N | 120 | 120 | 120 | 80 | 80 | 80 |
| Within-Run | 2.6 | 6.2 | 10.8 | 2.07 | 6.92 | 15.13 |
| %CV | 1.7 | 1.7 | 1.4 | 2.5 | 1.9 | 2.2 |
| Total | 2.6 | 6.2 | 10.8 | 2.07 | 6.92 | 15.13 |
| %CV | 3.1 | 3.0 | 2.8 | 5.4 | 4.2 | 4.6 |
4
Image /page/4/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the square is a white circle with the word "boehringer" written inside. To the right of the square is the word "Diagnostics" in a serif font.
Performance Characteristics:
Comparison to predicate
device, (cont.) ,
| Feature | CEDIA® Procainamide | TDx Procainamide |
|---|---|---|
| Lower | ||
| Detection | ||
| Limit | 0.4 µg/dL | 0.1 µg/dL |
| Linearity | 0.4 - 20 µg/dL (with a | |
| deviation from a linear line of | ||
| ±10%) | 0.0 - 20.0 µg/dL | |
| Method | ||
| Comparison | Vs Abbott TDx Procainamide | |
| Least Squares | ||
| $y =1.04x + 0.03$ | ||
| $r=0.9914$ | ||
| $SEE =0.42$ | ||
| $N=122$ | Vs Enzyme Immunoassay | |
| Procainamide | ||
| Least Squares | ||
| $y =1.01x - 0.18$ | ||
| $r=0.990$ | ||
| $N=262$ | ||
| Deming's: | ||
| $y =1.04x - 0.01$ | ||
| $r=0.9914$ | ||
| $SEE =0.30$ | ||
| $N=122$ |
5
Image /page/5/Picture/0 description: The image shows the logo for Boehringer Mannheim Diagnostics. The logo consists of a black square with the word "mannheim" written vertically on the left side. Inside the square is a white circle with the word "boehringer" written inside. To the right of the square is the word "Diagnostics" in a serif font.
Performance Characteristics:
Comparison
to predicate device, (cont.)
| Feature | CEDIA® Procainamide | TDx Procainamide |
|---|---|---|
| Interfering | ||
| substances | No interference at: | No interference at: |
| Bilirubin | 66 mg/dL | 15 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Lipemia | 1000 mg/dL | 1200 mg/dL |
| Protein | 6.5 g/dL Albumin | |
| 10 g/dL IgG | 9.5 mg/dL | |
| Rheumatoid | ||
| Factor | 66 IU/ml | N/A |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| N-Acetyl- | ||
| procainamide | 1.0 | 1.0 |
| Desethyl-N- | ||
| Acetyl- | ||
| procainamide | 0.1 | None Detected |
| Desethyl | ||
| procainamide | 16.3 | 15 |
| Procaine HCl | 1.7 | N/A |