BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A

K082661 · Princeton BioMeditech Corp. · GTY · Oct 6, 2008 · Microbiology

Device Facts

• Record ID: K082661
• Device Name: BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
• Applicant: Princeton BioMeditech Corp.
• Product Code: GTY · Microbiology
• Decision Date: Oct 6, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Intended Use

To aid in the early diagnosis of Group A Streptococcal infection, in vitro qualitative test

Device Story

StatusFirst Strep A is an in vitro diagnostic immunoassay for qualitative detection of Group A streptococcal antigen from throat swab specimens. Used in physician offices, hospitals, and clinical laboratories to aid clinical diagnosis of Group A streptococcal infection. Device provides rapid visual results to healthcare providers, facilitating timely clinical decision-making and patient management.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Solid-phase immuno-chromatographic assay. Reagents: 2M sodium nitrite (Reagent A) and 0.2M phosphoric acid (Reagent B). Specimen: throat swab. Visual reading method. No electronic or software components.

Indications for Use

Indicated for the qualitative detection of Group A streptococcus from throat swab specimens to aid in the early diagnosis of Group A Streptococcal infection.

Regulatory Classification

Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K082661

Applicant: Princeton BioMeditech Corp.

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 (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
K983386/A001, BioStrep A; K971349, BioSign Strep A and K040708/A002, StatusFirst Strep A.

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).
Indications for use did not change.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
This change was for a change to the incubation time for the antigen extraction in the Strep A tests from the current 2-5 minutes to 1-2 minutes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and test performance.

| Features | | Pre-amended devices
k971349, k983386, k040708 | Amended devices |
| --- | --- | --- | --- |
| Scientific principle and technology | | Solid phase immuno-chromatographic assay | Same as pre-amended device |
| Intended use | | To aid in the early diagnosis of Group A Streptococcal infection, in vitro qualitative test | Same as pre-amended device |
| Analyte | | Group A streptococcus | Same as pre-amended device |
| Antibodies | | Antibodies to group A streptococcus | Same as pre-amended device |
| Specimen collection | | Throat swab | Same as pre-amended device |
| Extraction Reagent volume | | 4 drops of Reagent A and 4 drops of Reagent B | Same as pre-amended device |
| Extraction reagent concentration | A | 2M sodium nitrite | Same as pre-amended device |
| | B | 0.05M phosphoric acid | 0.2M phosphoric acid |
| Incubation time for extraction of antigen | | 2 min | 1 min |
| Result reading time after extracted sample application | | 5-10 min | Same as pre-amended device |
| Result reading method | | Visual Reading | Same as pre-amended device |
| Sensitivity | | Detects1.5x10^{5} CFU/mL | Same as pre-amended device |
| Manufacturer | | Princeton BioMeditech Corp. | Same as pre-amended device |

5. A Design Control Activities Summary which includes:

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a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

The sponsor submitted all the Design Control studies. See attached reviewer's memo.

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.