K Number
K971909
Device Name
VIRGO AMA ELISA KIT
Date Cleared
1997-06-20

(28 days)

Product Code
Regulation Number
866.5090
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of antimitochondrial antibodies in human serum. The presence of mitochondrial antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of primary biliary cirrhosis(PBC)
Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to mitochondrial antigen in human serum. The ELISA methodology is commonly used for serum antibody evaluations. Purified mitochondrial antigen 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 antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.
More Information

Not Found

Not Found

No
The description details a standard ELISA assay with no mention of AI or ML components in the methodology or performance evaluation.

No
This device is an in vitro diagnostic (IVD) test designed to detect and measure antimitochondrial antibodies for diagnostic purposes, not to treat a condition.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can aid in the diagnosis of primary biliary cirrhosis (PBC)".

No

The device description clearly outlines a physical laboratory assay (ELISA) involving reagents, microwell plates, and an EIA Plate reader, which are hardware components.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it is for the "detection and measurement of antimitochondrial antibodies in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis.
  • Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA)" which is a common laboratory technique performed in vitro on biological samples.
  • Sample Type: The device uses "human serum," which is a biological specimen obtained from a human.
  • Purpose: The results are intended to "aid in the diagnosis of primary biliary cirrhosis (PBC)," which is a diagnostic purpose.

All of these points align with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of antimitochondrial antibodies in human serum. The presence of mitochondrial antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of primary biliary cirrhosis(PBC).

Product codes

82 DBM

Device Description

An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to mitochondrial antigen in human serum.

The ELISA methodology is commonly used for serum antibody evaluations. Purified mitochondrial antigen 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 antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). After the reaction is stopped, the color is read in an EIA Plate reader.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

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:
To evaluate precision, both inter-assay and intra-assay studies were conducted.

Inter-assay: Twelve different samples (9 positive and 3 negative) were assayed in triplicate twice a day for five different days. The assay controls {Positive, Negative, & Cutoff Serum} were assayed concurrently in triplicate twice each day for each of the five days.

Intra-assay: The same twelve samples (9 positive and 3 negative) were assayed 20 times in a single run. The assay controls {Positive and Cutoff Serum} were assayed concurrently 20 times.

Comparison Testing:
A total of 154 serum specimens (68 from individuals with known or suspected liver disease, 86 from normal apparently healthy donors) were concurrently assayed by both the predicate device and the proposed device.

Liver disease specimens (n = 68): 61 positive, 7 negative by both proposed and predicate devices.
Normals (n = 86): 86 negative by both proposed and predicate devices, 0 positive.

Interfering Substances:
Lipemic, icteric, and hemolytic samples were evaluated. Results indicate no significant effect (

§ 866.5090 Antimitochondrial antibody immunological test system.

(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).

0

K971909

JUN 20 1997

510(k) Summary

Submitter's Name/Contact Person 1.

Joseph M. Califano, Regulatory Affairs Manager

Address

Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154

(617) 890-3766 Phone: (617) 890-3748 Fax: email: jcalifano@hemagen.com

Date Prepared

19 May 1997

2. Device Names

Trade Name: VIRGO ® AMA ELISA KIT Common Name: Antimitochondrial antibody Kit (EIA method) Classification Name: Antimitochondrial antibody immunological test system

3. Predicate Device

1

Scimedx Mitochondrial Antibody Test System.

000001

1

3. Description of Device

An enzyme-linked immunosorbent assay (ELISA) designed for the detection and measurement of antibodies to mitochondrial antigen in human serum.

The ELISA methodology is commonly used for serum antibody evaluations. Purified mitochondrial antigen 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 antibodies remaining after the wash step. In the wells where the second antibody remains bound, the conjugated HRP catalyzes a color change in the substrate, tetramethyl benzidine (TMB). 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 antibodies to mitochondrial antigen in human serum.

5.(A) Technological Characteristics

Proposed Device

The VIRGO ® AMA ELISA KIT is an enzyme-linked immunosorbent assay. The device utilizes optical density as a measure of antibody presence, with an established cutoff between a positive and a negative reaction.

Predicate Device

2

The Scimedx Mitochondrial Antibody Test System 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, both inter-assay and intra-assay studies were conducted. The results are summarized below:

A Inter-assay

Twelve different samples {9 positive and 3 negative} were assayed in triplicate twice a day for five different days.

SampleMean ODStd. Dev.% CVMean UnitsStd. Dev.% CV
11.7210.1025.98.50.89.9
21.7140.1116.58.40.910.6
31.5740.0935.97.80.911.4
41.1160.0928.25.50.611.4
50.9390.0838.84.60.715.9
60.8580.0819.54.20.613.6
70.7290.0456.23.60.412.2
80.6790.0334.93.30.310.1
90.6730.07411.03.30.310.1
100.0200.019N/A0.10.1N/A
110.0250.025N/A0.10.1N/A
120.0270.015N/A0.10.1N/A

The assay controls {Positive, Negative, & Cutoff Serum} were assayed concurrently in triplicate twice each day for each of the five days.

SampleMean ODStd. Dev.% CV
Negative Control0.0030.003N/A
Positive Control1.2020.1109.2
Cutoff Serum0.2050.02411.6

3

Precision

Intra-assay B.

4

The same twelve samples {9 positive and 3 negative} were assayed 20 times in a single run.

SampleMean ODStd. Dev.% CVMean UnitsStd. Dev.% CV
11.3620.0503.79.31.010.7
21.2430.0342.78.40.89.6
31.3540.0664.99.20.89.1
40.8220.0587.05.60.59.2
50.6080.0437.24.10.410.2
60.6360.0548.54.30.613.7
70.6000.0396.54.10.411.0
80.5590.0305.43.80.49.6
90.5320.0336.13.60.49.7
100.0100.002N/A0.070.01N/A
110.0090.002N/A0.060.01N/A
120.0100.001N/A0.070.01N/A

The assay controls {Positive and Cutoff Serum} were assayed concurrently 20 times.

SampleMean ODStd. Dev.% CV
Positive Control1.0470.0403.8
Cutoff Serum0.1490.01510.2

4

Comparison Testing

Companson 1 estima
A total of 154 serum specimently assayed by both the production of the predicate
A total of 154 serum specitly books, were concurrently assayed by bellevi A total of 154 serum speciment (68 from individuals with known of the discussion,
86 from normal apparently healthy donos) were concurrently assayed by both the follow: A total 01 104 Solan of 104 series are presented in the tables that he mail more.
device and the proposed device. The results are presented in the tables that more.

Table 1 Combined known or suspected liver disease specimens. n = 68

Predicate Device
PositiveNegativeTotal
Proposed Device
Positive61061
Negative077
Total61768

relative Sensitivity = 100.0 % {61/61}, ... confidence interval = 94.1% to 100 %
Relative Sensitivity = 100.0 % {61/61}, ... confidence interval = 94.1% to 100 %
{{ if(

Table 2 Normals. n = 86

Predicate Device

PositiveNegativeTotal
Proposed Device
Positive000
Negative08686
Total08686

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5

Interfering Substances

Lipemic, icteric, and hemolytic samples were evaluated with the assay following Elpenine, and nemoryto bampio "interference Testing in Clinical NGCCS Document E. The results indicate that there is no significant effect (