(118 days)
No
The device description details a standard ELISA assay which relies on biochemical reactions and photometric measurement, with no mention of AI or ML components for data analysis or interpretation.
No.
This device is an in-vitro diagnostic test used to detect antibodies for aid in diagnosis, not to treat or cure a disease.
Yes
The device is explicitly stated as "an aid in the diagnosis of Systemic Sclerosis (SSc)" and "intended for in-vitro diagnostic use."
No
The device description clearly outlines a laboratory-based ELISA kit, which involves physical reagents, incubation steps, and photometric measurement, indicating it is a hardware-based in-vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use."
- Purpose: The device is designed to detect anti-RNA Polymerase III antibodies in human serum, which is a biological sample taken from the body.
- Diagnostic Aid: The test result is used "as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings." This clearly indicates its role in the diagnostic process.
- Intended User/Care Setting: The device is intended for use in "clinical (hospital and reference) laboratories," which are typical settings for in vitro diagnostic testing.
- Device Description: The description details the biological target (anti-RNA Polymerase III antibodies), the sample type (human serum), and the method used (ELISA), all of which are characteristic of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The anti-RNA Polymerase III ELISA Kit is a semiquantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.
Product codes
LJM, NYO
Device Description
This device is an aid to the diagnosis of SSc. Systemic sclerosis (SSc) is an autoimmune disease characterized by microvascular damage and fibrosis of the skin and internal organs. RNA polymerase(RNAP) I, II and III are major targets of autoantibody responses in SSc patients. Each RNAP catalyzes transcription of unique sets of genes: RNAP I transcribes ribosomal RNA genes, RNAP II transcribes all protein coding genes and several small nuclear RNA genes, and RNAP III transcribes genes that produce small stable RNAs including 5S and transfer RNAs. Anti-RNAP I and anti-RNAP III antibodies are almost always present together (anti-RNAP I/II), and some sera contain anti-RNAP II antibody as well. Anti-RNAP I/II antibodies are the most common SSc related antibodies in white North American patients with SSc and is associated with diffuse cutaneous involvement, a high frequency of "renal crisis", and high mortality. In addition, it has been shown that some SSc sera contain autoantibodies recognizing RNAP II but not RNAP I or III. Antibodies to RNAP II are also present in sera from some patients with systemic lupus erythematosus (SLE) or overlap syndrome. PRINCIPLE: The anti-RNA Polymerase III ELISA Kit measures anti-RNAP III antibodies present in the serum by ELISA. Diluted Calibrators and patient serum are added to microwell coated with RNAP III antigens, allowing anti-RNAP III antibodies to react with the immobilized antigen (Sample incubation). After washing to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG is added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.
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
Performance characteristics were established in a clinical trial via comparison with a research method, Immunoprecipitation, AND K972145, HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K 060431
510(k) Summary MBL INTERNATIONAL CORPORATION 15b Constitution Wav Woburn, Ma 01801 Phone: 800.200.5459 or 781.939.6964 Fax: 781.939.6963 Contact: Yusuke Kobe, Vice President, Sales and Marketing Prepared February 14, 2006
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- Identification of the Device: Proprietary-Trade Name: Anti RNA Polymerase III ELISA Kit Classification Name/Product Codes: LJM Common/Usual Name: ELISA In-Vitro Diagnostic Kit
-
- Indications for Use (intended use) : The anti-RNA Polymerase III ELISA Kit is a semiquantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.
-
- Description of the Device: This device is an aid to the diagnosis of SSc. Systemic sclerosis (SSc) is an autoimmune disease characterized by microvascular damage and fibrosis of the skin and internal organs. RNA polymerase(RNAP) I, II and III are major targets of autoantibody responses in SSc patients. Each RNAP catalyzes transcription of unique sets of genes: RNAP I transcribes ribosomal RNA genes, RNAP II transcribes all protein coding genes and several small nuclear RNA genes, and RNAP III transcribes genes that produce small stable RNAs including 5S and transfer RNAs. Anti-RNAP I and anti-RNAP III antibodies are almost always present together (anti-RNAP I/II), and some sera contain anti-RNAP II antibody as well. Anti-RNAP I/II antibodies are the most common SSc related antibodies in white North American patients with SSc and is associated with diffuse cutaneous involvement, a high frequency of "renal crisis", and high mortality. In addition, it has been shown that some SSc sera contain autoantibodies recognizing RNAP II but not RNAP I or III. Antibodies to RNAP II are also present in sera from some patients with systemic lupus erythematosus (SLE) or overlap syndrome. PRINCIPLE: The anti-RNA Polymerase III ELISA Kit measures anti-RNAP III antibodies present in the serum by ELISA. Diluted Calibrators and patient serum are added to microwell coated with RNAP III antigens, allowing anti-RNAP III antibodies to react with the immobilized antigen (Sample incubation). After washing to remove any unbound serum proteins, horseradish peroxidase conjugated anti human IgG is added and incubated (Conjugate incubation). Following another washing step, the peroxidase substrate is added and incubated for an additional period of time (Substrate incubation). Acid solution is then added to each well to terminate the enzyme reaction and to stabilize the color development. The assay can be quantified by measuring the reaction photometrically and plotting the results.
1
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- Safety and Effectiveness, comparison to predicate device. The results of clinical and nonclinical testing indicates that the new device is as safe and effective as the predicate devices and methods.
| Characteristic | K040200
MESACUP-2 TEST
CENP-B, MBL
International
(formerly Rhigene) | K972145, HEP-
2000
FLUORESCENT
ANA-RO TEST
SYSTEM, Immuno
Concepts | Anti RNA
Polymerase III
ELISA Kit |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The MESACUP-2 Test
CENP-B is a semi-
quantitative enzyme-
linked immunosorbent
assay (ELBA) for the
detection of anti-
CENP-B antibodies
inhuman serum. The
MESACUP-2 Test
CENP-B is intended
for in vitro diagnostic
use as an aid in the
diagnosis of CREST
syndrome and related
connective tissue
diseases.
The MESACUP-2 Test
CENP-B is intended to
be used by clinical
(hospital and
reference) laboratories. | This is an indirect
fluorescent antibody
test for the semi-
quantitative detection
of antinuclear
antibodies in human
serum, with specific
identification of
autoantibodies to the
SS-A/Ro antigen.
This test system is to
be used as an aid in
the detection of
antibodies associated
with system
rheumatic disease | The anti-RNA
Polymerase III
ELISA Kit is a semi-
quantitative, enzyme-
linked
immunosorbent assay
(ELISA) for the
detection of anti-
RNA Polymerase III
antibodies in human
serum. The anti-RNA
Polymerase III
ELISA Kit is
intended for in-vitro
diagnostic use |
| Technology | ELISA | Indirect fluorescent | ELISA |
| Detect what? | ANA | ANA | ANA |
| Disease | Crest syndrome | Multiple anti-immune
diseases, systemic
rheumatic disease | Systemic sclerosis
(SSc) |
| Test fluid | Serum | Serum | Serum |
| USE | IVD | IVD | IVD |
6. Substantial Equivalence Chart
7. Conclusion
After analyzing clinical and non-clinical testing data, it is the conclusion of MBL INTERNATIONAL CORPORATION that the Anti RNA Polymerase III ELISA Kit is as safe and effective as the predicate devices, thus rendering it substantially equivalent to the predicate device. Performance characteristics were established in a clinical trial via comparison with a research method, Immunoprecipitation, AND K972145, HEP-2000 FLUQRESCENT ANA-RO TEST SYSTEM.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures in motion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 19 2006
MBL International Corporation c/o Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K060431
Trade/Device Name: MBL Anti-RNA Polymerase III ELISA Kit Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological system Regulatory Class: Class II Product Code: NYO Dated: February 16, 2006 Received: February 27, 2006
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Rockerf
Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The anti-RNA Polymerase III ELISA Kit is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of anti-RNA Polymerase III antibodies in human serum. The test result is used as an aid in the diagnosis of Systemic Sclerosis (SSc) in conjunction with the clinical and other laboratory findings. The anti-RNA Polymerase III ELISA Kit is intended for in-vitro diagnostic use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M. Chan
060431