(175 days)
K 771376A
Not Found
No
The description details a standard ELISA assay which relies on biochemical reactions and optical density readings, with no mention of AI or ML in the process or analysis.
No
The device is an ELISA test designed for the detection and measurement of circulating antibodies to native DNA, used for diagnostic purposes, not for treating or preventing disease.
Yes
The device is an ELISA designed for the detection and measurement of circulating antibodies to native DNA, which are associated with Systemic Lupus Erythematosus (SLE). This direct association with a disease for detection and measurement purposes qualifies it as a diagnostic device.
No
The device description clearly outlines a laboratory assay (ELISA) involving physical reagents, microwell plates, and an EIA Plate reader, which are hardware components. It is not solely software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is designed for the "detection and measurement of circulating antibodies to native DNA" in human serum. This clearly indicates it's used to analyze a sample taken from the human body (in vitro) to provide information about a person's health status (diagnostic).
- Device Description: The description details an ELISA method using human serum to detect antibodies. This is a classic example of an in vitro diagnostic test.
- Performance Studies: The performance studies involve testing human serum specimens from patients and blood donors, further confirming its use with biological samples outside the body.
The core purpose of the device is to analyze a biological sample (serum) to aid in the diagnosis or assessment of a medical condition (systemic lupus erythematosus). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating antibodies to native DNA. These autoantibodies are often associated with systemic lupus erythematosus (SLE) and give positive results in screening tests for antinuclear antibodies.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to native DNA in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified native DNA has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.
A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's DNA antibodies that remain after the wash step. In the wells where the second antibody remains bound. the conjugated HRP catalyzes a color change in the substrate. After the reaction is stopped, the color is read in an EIA Plate reader.
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)
Precision:
Inter-assay reproducibility (Between-run): Eight different serum samples were assayed five times each, twice a day, on five different days (a total of 50 readings).
Intra-assay reproducibility (Within-run): Eight different samples were assayed 20 consecutive times in a single run.
Verification of the DNA Calibrators: The kit calibrators have been compared to the World Health Organization Standard for Anti-Double Stranded DNA (ANTI-dsDNA) 1st International Standard, Code Wo / 80 A study was conducted to demonstrate the high degree of correlation that exists between the kit calibrators and the W.H.O. Standard.
Comparison Testing:
The Hemagen dsDNA Kit and the Hemagen VIRGO Anti-nDNA IgG IFA Kit were used to assay 100 serum specimens from different patients with known or suspected autoimmune disease. Forty (40) specimens from apparently healthy blood donors were also assayed with the Hemagen dsDNA Kit and the Hemagen VIRGO Anti-nDNA IgG IFA Kit.
Results for disease state patients (N=100):
- Initial testing with Proposed Device Positive: 23 (Predicate Positive), 2 (Predicate Negative).
- Initial testing with Proposed Device Negative: 7 (Predicate Positive), 68 (Predicate Negative).
- Final results for disease state patients (N=100) after discrepant sample evaluation: Proposed Device Positive: 23 (Predicate Positive), 2 (Predicate Negative). Proposed Device Negative: 0 (Predicate Positive), 75 (Predicate Negative).
Results for normal blood donors (N=40): Proposed Device Positive: 0 (Predicate Positive), 0 (Predicate Negative). Proposed Device Negative: 0 (Predicate Positive), 40 (Predicate Negative).
Interfering Substances: Lipemic, hemolytic, and icteric samples were evaluated with the assay in accordance with NCCLS Document EP7-P Proposed Guideline " Interference Testing in Clinical Chemistry." The results indicate that there is no significant effect (
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
510(k) Summary
1. Submitter's Name/Contact Person
DEC - 5 1996
Joseph M. Califano, Manager, Regulatory Affairs
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
Phone: (617) 890-3766 (617) 890-3748 Fax:
14 June 1996 Date Prepared:
2. Device Name
Trade Name: Hemagen ® DNA Kit (EIA method) Common Name: Anti-DNA Classification Name: Anti-DNA Antibody, Antigen and Control
3. Predicate Device
Hemagen VIRGO ® Anti-nDNA IgG IFA Kit {Reference 510 (k) No. K 771376A}
1
3. Description of Device
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to native DNA in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified native DNA has been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.
A second antibody which is conjugated to horseradish peroxidase (HRP) is used to recognize the "heavy + light" chain regions of the patient's DNA antibodies that remain after the wash step. In the wells where the second antibody remains bound. the conjugated HRP catalyzes a color change in the substrate. After the reaction is stopped, the color is read in an EIA Plate reader.
4. Intended Use of Device
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of circulating antibodies to native DNA. These autoantibodies are often associated with systemic lupus erythematosus (SLE) and give positive results in screening tests for antinuclear antibodies.
5.(A) Technological Characteristics
Proposed Device
The Hemagen dsDNA Kit is an enzyme-linked immunosorbent assay. The device utilizes optical density as a measure of antibody presence, with an established cutoff point between a positive and a negative reaction.
Predicate Device
The Hemagen VIRGO Anti-DNA IgG {heavy + light} IFA Kit is an indirect fluorescent antibody assay. The device utilizes the indirect method of fluorescent antibody staining. The resultant level of observed fluorescence is used to determine the presence or absence of antibodies.
2
5.(B) Performance Data
Precision .
To evaluate precision, inter-assay and intra-assay studies were conducted.
A. Inter-assay reproducibility {Between-run}
Eight different serum samples were assayed five times each, twice a day, on five different days (a total of 50 readings)
| Sample | Mean IU/mL | Std. Dev. | % CV | Mean O.D. | Std. Dev. | % CV |
|---|---|---|---|---|---|---|
| 1 | 102.1 | 11.3 | 11.1 | 0.617 | 0.05 | 8.3 |
| 2 | 102.4 | 6.4 | 6.2 | 0.620 | 0.05 | 7.4 |
| 3 | 90.1 | 6.5 | 7.2 | 0.553 | 0.04 | 7.7 |
| 4 | 55.3 | 5.2 | 9.4 | 0.356 | 0.04 | 9.9 |
| 5 |