← Product Code [MYI](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI) · K121905

# ALERE PBP2A TEST (K121905)

_Alere Scarborough, Inc. · MYI · Jul 26, 2012 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K121905

## Device Facts

- **Applicant:** Alere Scarborough, Inc.
- **Product Code:** [MYI](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI.md)
- **Decision Date:** Jul 26, 2012
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Alere™ PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin-binding protein 2a (PBP2a) in isolates identified as Staphylococcus aureus, as an aid in detecting methicillin-resistant Staphylococcus aureus (MRSA). The Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections.

## Device Story

The Alere™ PBP2a Test is a rapid, qualitative, in vitro immunochromatographic membrane assay. It utilizes monoclonal antibodies immobilized on a nitrocellulose membrane to detect PBP2a protein directly from bacterial isolates sampled from culture plates. The test strip includes a sample pad, blue conjugate pad, and absorption pad. The operator elutes the bacterial isolate into an assay tube, adds reagent, and inserts the dipstick. Results are read visually after 5 minutes. The device is intended for use in laboratory settings to assist in the identification of MRSA. It provides a rapid detection method for the PBP2a marker, which is associated with methicillin resistance in S. aureus, thereby aiding clinical decision-making regarding infection control or further diagnostic testing.

## Clinical Evidence

Clinical performance established in a multi-center study (n=457 S. aureus samples) compared to 30 µg cefoxitin disk diffusion. Sensitivity ranged from 98.1% to 99.5% and specificity was 98.8% across three agar types (Tryptic Soy, Columbia, and Mueller Hinton). Reproducibility study at 3 sites showed 97.3% agreement with expected results.

## Technological Characteristics

Lateral flow immunochromatographic assay. Components include nitrocellulose membrane, sample pad, blue conjugate pad, and absorption pad. Employs monoclonal antibodies for PBP2a detection. Visual readout. Manual, point-of-care style test strip.

## Regulatory Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

## Predicate Devices

- Clearview® Exact PBP2a Test ([K091766](/device/K091766.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K121905

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

Clearview® Exact PBP2a Test (k091766).

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. This Special 510(k) submission presents a Device Modification for a materials change to the Clearview® Exact PBP2a Test (K091766), an immunochromatographic test for the detection of penicillin - binding protein 2a (PBP2a) in isolates of Staphylococcus. Specifically the control line is changing from rabbit anti - mouse Igs to chicken IgY. The modified test has the same scientific technology and the intended use of the device, as described in its labeling, has not changed as a result of this modification. This modification has not affected or caused any changes to the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of this device.

4. Comparison Information (similarities and differences)

|  PARAMETER | UNMODIFIED (K091766) | MODIFIED TEST  |
| --- | --- | --- |
|  INTENDED USE | The Alere™ PBP2a Test is a qualitative, in vitro immunochromatographic assay for the detection of penicillin - biding protein 2a (PBP2a) isolates identified as Staphylococcus aureus, as an aid in detecting methicillin - resistant Staphylococcus aureus (MRSA). The Alere™ PBP2a Test is not intended to diagnose MRSA nor to guide or monitor treatment for MRSA infections. | Same  |
|  ANALYTE/ MODE OF DETECTION | PBP2a (penicillin binding protein 2a) | Same  |
|  TECHNOLOGY | Detection with latex particles sensitized with a monoclonal antibody against PBP2a | Same  |
|  SPECIMEN TYPE | Isolates identified as Staphylococcus species | Same  |
|  ANTIGEN (SAMPLE LINE) DETECTION REAGENTS | Mouse anti PBP2a monoclonal antibody immobilized for capture and conjugated to visualizing particles | Same  |

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|  PARAMETER | UNMODIFIED (K091766) |   | MODIFIED TEST  |
| --- | --- | --- | --- |
|  PERFORMANCE CHARACTERISTICS | SENSITIVITY (95% CI) | SPECIFICITY (95% CI) | Performance claims are unchanged from the original 510(k)  |
|  Tryptic Soy Agar with 5% Sheep Blood | 98.1 % (95.2% 99.3%) | 98.8% (96.5% 99.6%)  |   |
|  Columbia Agar with 5% Sheep Blood | 99.0 % (96.6% 99.7%) | 98.8 % (96.5% 99.6%)  |   |
|  Mueller Hinton with 1μg oxacillin induction | 99.5 % (97.4% 99.9%) | 98.8 % (96.5% 99.6%)  |   |
|  CONTROL LINE DETECTION REAGENTS | Rabbit anti mouse immunoglobulin for capture and anti PBP2a antibody conjugate |   | Chicken IgY immobilized for capture and species anti IgY conjugate  |

5. A Design Control Activities Summary which includes:

The Sponsor provided a signed statement that:

a) Alere Scarborough, Inc. is in conformance with the design control requirements as specified in 21 CFR 820.30 and the records are available for review.
b) The verification activities, as required by the risk analysis, for the modification were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K121905](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/MYI/K121905)

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