BIOPLEX 2200 APLS IGM

• K Number: K130528
• Device Name: BIOPLEX 2200 APLS IGM
• Manufacturer: Bio-Rad Laboratories
• Date Cleared: 2013-10-21 ( 234 days)
• Product Code: MID JIX JJX MSV
• Regulation Number: 866.5660

Intended Use

The BioPlex®2200 Antiphospholipid Syndrome (APLS) IgM kit is a multiplex flow immunoassav intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The BioPlex 2200 APLS IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack. The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding BioPlex 2200 APLS IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 APLS IgM Control Set has not been established with any other Antiphospholipid assay.

Device Description

BioPlex® 2200 APLS IgM kit includes the following components: - o One (1) 10 mL vial of Bead Set containing two different populations of dyed beads coated with Cardiolipin (CL) and Beta-2-Glycoprotein I (B2GPI). an Internal Standard bead (ISB). a Serum Verification bead (SVB), and a Reagent Blank bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with glycerol and protein stabilizers (porcine), and ProClin 300 (< 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. - One (1) 5 mL vial of Conjugate containing phycoervthrin conjugated murine . monoclonal anti-human IgM and phycoerythrin conjugated murine monoclonal anti-human FXIII in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with protein stabilizers (bovine), and ProClin 300 (< 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. - One (1) 10 mL vial of Sample Diluent containing buffer with protein stabilizers . (bovine and murine), and ProClin 300 (< 0.3%). sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. BioPlex® 2200 APLS IgM Calibrator set contains seven 0.5 mL vials of human antibodies to CL or B2GPI in a human serum matrix made from defibrinated plasma with ProClin 300 (≤ 0.3%), sodium benzoate (< 0.1%) and sodium azide (< 0.1%) as preservatives. BioPlex® 2200 APLS [gM Control set contains four 1.5-mL vials of Positive controls of human antibodies to CL or ß2GPI and two vials of Negative Controls in a human serum matrix made from defibrinated plasma; and, in a human serum matrix made from defibrinated plasma with ProClin 300 (≤0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. Additional materials required but not supplied include BioPlex® 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS) with ProClin® 300 (0.03%) and sodium azide (<0.1%) as preservatives; and BioPlex® 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20 with ProClin® 300 (<0.03%) and sodium azide (<0.1%) as preservatives.

Predicate Devices

K092181, K091556

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a multiplex flow immunoassay kit and its components, along with performance studies based on standard laboratory methods. There is no mention of AI or ML in the intended use, device description, or performance summaries.

Therapeutic

No.

This device is intended for in vitro diagnostic use, specifically for the semi-quantitative detection of certain antibodies to aid in the diagnosis of Antiphospholipid Syndrome (APS). It does not provide treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the test system is "used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders," which directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly lists physical components such as vials of beads, conjugate, and diluent, which are reagents used in a laboratory assay. It also mentions the need for a Bio-Rad BioPlex 2200 System, which is a hardware instrument. This indicates it is a system involving both hardware and reagents, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma... In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS)..." This clearly indicates that the device is used to examine specimens derived from the human body to provide information for the diagnosis of a disease.
• Device Description: The description details the components of the kit, including reagents, calibrators, and controls, which are typical components of an in vitro diagnostic assay.
• Performance Studies: The document includes a "Summary of Performance Studies" which describes various analytical and clinical studies conducted to evaluate the performance of the device, such as precision, linearity, analytical specificity, cross-reactivity, assay cut-off, method comparison, matrix comparison, and clinical sensitivity and specificity. These studies are required for the regulatory approval of IVD devices.
• Key Metrics: The inclusion of "Key Metrics" like sensitivity and specificity further supports its classification as an IVD, as these are standard performance measures for diagnostic tests.
• Predicate Device(s): The mention of "Predicate Device(s)" with K numbers (regulatory submission numbers) indicates that this device is being compared to previously cleared IVD devices.

All of these elements are characteristic of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BioPlex®2200 Antiphospholipid Syndrome (APLS) IgM kit is a multiplex flow immunoassav intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.

The BioPlex 2200 APLS IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack.

The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding BioPlex 2200 APLS IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 APLS IgM Control Set has not been established with any other Antiphospholipid assay.

Product codes (comma separated list FDA assigned to the subject device)

MID, MSV, JIX, JJX

Device Description

BioPlex® 2200 APLS IgM kit includes the following components:

• One (1) 10 mL vial of Bead Set containing two different populations of dyed beads coated with Cardiolipin (CL) and Beta-2-Glycoprotein I (B2GPI). an Internal Standard bead (ISB). a Serum Verification bead (SVB), and a Reagent Blank bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with glycerol and protein stabilizers (porcine), and ProClin 300 (

Regulation Number and Section

§ 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).

Summary

0

BioPlex® 2200 Antiphospholipid Syndrome (APLS) IgM 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 APLS IgM kit.

510(k) Number: K130528

Summary Preparation Date: October 18, 2013

OCT 2 1 2013

Applicant: Bio-Rad Laboratories

Contact:

Juang Wang Regulatory Affairs Representative 5500 East Second Street Benicia CA 94510 Ph: [phone] Fax: [phone]

Purpose for Submission:

New Device

Measurand:

IgM antibodies to Cardiolipin (CL) IgM antibodies to Beta-2-Glycoprotien I (ß2GPI)

Type of Test:

Semi-Quantitative multiplexed flow, bead-based immunoassay

Proprietary and Established Names:

BioPlex® 2200 APLS IgM kit BioPlex® 2200 APLS IgM Calibrator Set BioPlex® 2200 APLS IgM Control Set

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Regulatory Information:

• 1. Regulation section:
  • 21 CFR §866.5660 Multiple autoantibodies immunological test system 21 CFR $862.1150 - Calibrator 21 CFR §862.1660 - Quality Control Material (assayed and unassayed)
• 2. Classification:

Class II (Assavs, Calibrator) Class 1 (Controls)

• 3. Product code:
     MID. System Test. Anti-Cardiolipin Immunological MSV. Antibodies. B2- Glycoprotein 1 (B2-GPI) JIX. Calibrator, Multi-Analyte Mixture JJX. Single (specified) Analyte Controls (Assayed and Unassayed)

4. Panel:

Immunology (82) (Assays) Chemistry (75) (Controls)

Intended Use:

l . Intended use(s):

The BioPlex®2200 Antiphospholipid Syndrome (APLS) IgM kit is a multiplex flow immunoassav intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders.

The BioPlex 2200 APLS IgM kit is intended for use with the Bio-Rad BioPlex 2200 System.

The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack.

The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding BioPlex 2200 APLS IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 APLS IgM Control Set has not been established with any other Antiphospholipid assay.

2

• 2. Indication(s) for use: Same as Intended Use
• 3. Special conditions for use statement(s): For prescription use only
• 4. Special instrument requirements: Bio-Rad BioPlex® 2200 Svstem

Device Description:

BioPlex® 2200 APLS IgM kit includes the following components:

• o One (1) 10 mL vial of Bead Set containing two different populations of dyed beads coated with Cardiolipin (CL) and Beta-2-Glycoprotein I (B2GPI). an Internal Standard bead (ISB). a Serum Verification bead (SVB), and a Reagent Blank bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with glycerol and protein stabilizers (porcine), and ProClin 300 ( 112 MPL-U/mL for aCL and > 112 U/mL for aß2GPI IgM.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

There is no international or certified reference material available for anti-CL and anti-B2GPI IgM. The calibrators are assigned relative arbitrary units (MPL-U/mL for aCL and U/mL for aß2GPI).

Value Assignment:

The calibrators are manufactured independently from the controls, and are stabilized with Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 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)

Image /page/20/Picture/13 description: The image shows the text "Maria M. FC Chan -S" in a bold, sans-serif font. The letters are black and have a slightly rough or textured appearance. The letters "FC" are stylized with a geometric pattern, making them stand out from the rest of the text.

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 130528

Device Name

BioPlex® 2200 Antiphospholipid Syndrome (API.S) IgM Calibrator Set

Indications for Use (Describe)

The BioPlex 2200 APLS IgM Calibrator Set is intended for the corresponding BioPlex 2200 APLS IgM Reagent Pack.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 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)

Image /page/21/Picture/13 description: The image shows the name "Maria M. FC Chan -S" in a stylized font. The letters are large and bold, with a slightly rough, hand-drawn appearance. The name is arranged horizontally, with the first name "Maria" followed by the middle initial "M.", then "FC Chan", and finally "-S".

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.