(247 days)
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay kit and associated calibrators and controls. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on analytical and clinical validation metrics typical for such devices, not on the performance of an AI/ML algorithm.
No
This device is an in vitro diagnostic test designed to aid in the diagnosis of Celiac Disease by detecting specific autoantibodies, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test system is used "as an aid in the diagnosis of Celiac Disease".
No
The device description clearly outlines physical components such as vials of Bead Set, Conjugate, and Sample Diluent, which are chemical reagents used in an in vitro diagnostic assay. It also mentions the need for the Bio-Rad BioPlex 2200 System, which is a hardware instrument. Therefore, this is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the BioPlex 2200 Celiac IgA and IgG kits are "in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgA autoantibodies... and IgG autoantibodies... in human serum."
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. This description perfectly aligns with the intended use of the BioPlex 2200 Celiac kits, which analyze human serum samples to aid in the diagnosis of Celiac Disease.
N/A
Intended Use / Indications for Use
- l . Intended use(s):
BioPlex® 2200 Celiac IgA Kit
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy).
The BioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System.
BioPlex®2200 Celiac IgG Kit
The BioPlex 2200 Celiac IgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy).
The BioPlex 2200 Celiac IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
BioPlex® 2200 Celiac IgA Calibrator Set
The BioPlex 2200 Celiac IgA Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgA Reagent Pack.
BioPlex® 2200 Celiac IgG Calibrator Set
The BioPlex 2200 Celiac IgG Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgG Reagent Pack.
BioPlex® 2200 Celiac IgA Control Set
The BioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgA Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgA assays.
BioPlex® 2200 Celiac IgG Control Set
The BioPlex 2200 Celiac IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgG Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgG assays.
-
- Indication(s) for use: Same as Intended Use
Product codes (comma separated list FDA assigned to the subject device)
MVM, MST, JIX, JJY
Device Description
BioPlex® 2200 Celiac IgA and IgG kits include the following components:
- . One (1) 10 mL vial of Bead Set, containing dyed beads coated with recombinant antigens; an Internal Standard bead (ISB), a Serum Verification bead (SVB) and IgA Verification Bead (AVB) (in Celiac IgA only), in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with Glycerol and protein stabilizer (bovine and porcine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
K.130053
SEP 1 9 2013
BioPlex® 2200 Celiac IgA and IgG 510(k) Summary
Bio-Rad Laboratories hereby submits this 510(k) in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This summary of 510(k) safety and effectiveness information provides detail as a basis for a determination of substantial equivalence for the BioPlex® 2200 Celiac IgA and IgG kits.
510(k) Number: K130053
Summary Preparation Date: August 14, 2013
August 14, 2013
Applicant:
Bio-Rad Laboratories
Contact:
Juang Wang Regulatory Affairs Representative
Purpose for Submission: New Device
Measurand:
IgA and IgG antibodies to tissue Transglutaminase (tTG) IgA and IgG antibodies to deamidated gliadin peptide (DGP)
Type of Test:
Semi-Quantitative multiplexed flow, bead-based immunoassay
Proprietary and Established Names:
BioPlex® 2200 Celiac IgA kit BioPlex® 2200 Celiac IgG kit BioPlex® 2200 Celiac IgA Calibrator Set BioPlex® 2200 Celiac IgA Control Set BioPlex® 2200 Celiac IgG Calibrator Set BioPlex® 2200 Celiac IgG Control Set
1
Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| Autoantibodies, | |||
| endomysial(tissue | |||
| transglutaminase) | |||
| (MVM) | Class II | 21 CFR § 866.5660, | |
| Multiple autoantibodies | |||
| immunological test system. | Immunology (82) | ||
| Antibodies, Gliadin | |||
| (MST) | Class II | 21 CFR § 866.5750, | |
| Radioallergosorbent | |||
| (RAST) immunological test | |||
| system. | Immunology (82) | ||
| Calibrator, Multi-Analyte | |||
| Mixture | |||
| (JIX) | Class II | 21 CFR § 862.1150 - | |
| Calibrator | Clinical Chemistry | ||
| (75) | |||
| Multi-Analyte Controls | |||
| All kinds(assayed) | |||
| (JJY) | Class I | 21 CFR § 862.1660 - | |
| Quality Control Material | |||
| (Assayed and Unassayed) | Clinical Chemistry | ||
| (75) |
Intended Use:
- l . Intended use(s):
BioPlex® 2200 Celiac IgA Kit
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy).
The BioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System.
BioPlex®2200 Celiac IgG Kit
The BioPlex 2200 Celiac IgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy).
The BioPlex 2200 Celiac IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
2
BioPlex® 2200 Celiac IgA Calibrator Set
The BioPlex 2200 Celiac IgA Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgA Reagent Pack.
BioPlex® 2200 Celiac IgG Calibrator Set
The BioPlex 2200 Celiac IgG Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgG Reagent Pack.
BioPlex® 2200 Celiac IgA Control Set
The BioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgA Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgA assays.
BioPlex® 2200 Celiac IgG Control Set
The BioPlex 2200 Celiac IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgG Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgG assays.
-
- Indication(s) for use: Same as Intended Use
-
- Special conditions for use statement(s): For prescription use only
-
- Special instrument requirements: Bio-Rad BioPlex® 2200 System
Device Description:
BioPlex® 2200 Celiac IgA and IgG kits include the following components:
- . One (1) 10 mL vial of Bead Set, containing dyed beads coated with recombinant antigens; an Internal Standard bead (ISB), a Serum Verification bead (SVB) and IgA Verification Bead (AVB) (in Celiac IgA only), in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with Glycerol and protein stabilizer (bovine and porcine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (15.0 U/mL for anti-tTG IgA or IgG and for anti-DGP IgA or IgG are reported as positive.
Each laboratory should establish its own reference range pertinent to their specific patient populations.
Instrument Name:
The BioPlex 2200 System, software version 4.1
21
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/21/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is simple, clean, and easily recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2013
BIO-RAD LABORATORIES, INC. C/O DR. JUANG WANG REGULATORY AFFAIRS REPRESENTATIVE 5500 EAST 2ND ST. BENICIA, CA 94510
Re: K130053
Trade/Device Name: BioPlex® 2200 Celiac IgA kit BioPlex® 2200 Celiac lgG kit BioPlex® 2200 Celiac IgA Calibrator Set BioPlex® 2200 Celiac IgG Calibrator Set BioPlex® 2200 Celiac IgA Control Set BioPlex® 2200 Celiac IgG Control Set Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MVM, MST, JIX, JJX
Dated: August 22, 2013 Received: August 23, 2013
Dear Dr. Wang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of
22
Page 2-Dr. Juang Wang
medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Maria M. Chan -S
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
23
Indications for Use
510(k) Number (if known) K130053
Device Name BioPlex® 2200 Celiac IgA Kit
Indications for Use (Describe)
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminasc (1TG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the disease (gluten-sensitive enteropathy).
The BioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M.
1995
FORM FDA 3881 (6/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
24
Indications for Use
510(k) Number (if known) K130053
Device Name
BioPlex® 2200 Celiac IgA Control Set
Indications for Use (Describe)
The BioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Celiac IgA Control Set has not been established with any other anti-tissue Transglutaminase (ITG) and anti-deamidated gliadin peptide IgA assays.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -S
FDA
FORM FDA 3881 (6/13)
PSC Publishing Services (301) 443-6740 EP
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
25
Indications for Use
510(k) Number (if known) K130053
Device Name
BioPlex® 2200 Celiac IgA Calibrator Set
Indications for Use (Describe)
The BioPlex 2200 Celiac IgA Calibrator Set is intended for the BioPlex 2200 Celiac IgA Reagent Pack.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -
EXA
FORM FDA 3881 (6/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
PSC Publishing Services (3D) 443-6740 EF
26
Indications for Use
510(k) Number (if known) K130053
Device Name
BioPlex® 2200 Celiac IgG Control Set
Indications for Use (Describe)
The BioPlex 2200 Celiac IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the BioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Celiac IgG Control Set has not been established with any other anti-tissue Transglutaminase (ITG) and anti-deamidated gliadin peptide IgG assays.
Type of Use (Select one or both, as applicable) .
| X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan -
FDA
FORM FDA 3881 (6/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
27
Indications for Use
510(k) Number (if known) K130053
Device Name
BioPlex® 2200 Celiac IgG Calibrator Set
Indications for Use (Describe)
The BioPlex 2200 Celiac IgG Calibrator Set is intended for the BioPlex 2200 Celiac IgG Reagent Pack.
Type of Use (Select one or both, as applicable)
|x| Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Chan
FDA
FORM FDA 3881 (6/13)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
28
Indications for Use
510(k) Number (if known) K130053
Device Name BioPlex® 2200 Celiac IgG Kit
Indications for Use (Describe)
The BioPlex 2200 Celiac IgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (1TG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the disease (gluter-sensitive enteropathy).
The BioPlex 2200 Celiac IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
Type of Use (Select one or both, as applicable)
| > Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Maria M. Char
FDA
FORM FDA 3881 (6/13)
PSC Publishing Services (3(1) 443-6740