AMPLIVUE GBS ASSAY

K133503 · Quidel Corporation · NJR · Dec 20, 2013 · Microbiology

Device Facts

• Record ID: K133503
• Device Name: AMPLIVUE GBS ASSAY
• Applicant: Quidel Corporation
• Product Code: NJR · Microbiology
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The AmpliVue GBS Assay is a qualitative in vitro diagnostic test for the rapid detection of Group B Streptococcus from vaginal/rectal swabs from antepartum women following 18 to 24 hours of incubation in an LIM enrichment broth culture. The AmpliVue" GBS Assay utilizes helicase-dependent amplification (HDA) of the thiolase (atoB) gene sequence and a self-contained disposable amplification detection device that allows for manual evaluation of assay results. Results can be used as an aid in determining the colonization status of antepartum women. The AmpliVue GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The AmpliVue® GBS Assay is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Device Story

AmpliVue GBS Assay detects Group B Streptococcus (GBS) in enriched vaginal/rectal swab cultures. Process: manual heat lysis of cultured specimen; isothermal helicase-dependent amplification (HDA) of thiolase (atoB) gene; manual detection via self-contained disposable cassette. Cassette uses vertical-flow DNA detection strip with anti-FITC/anti-DNP antibodies and streptavidin-conjugated color particles. Output: visual colored lines (test/control) in cassette window. Used in hospital, reference, or state laboratories by trained personnel. Provides rapid colonization status aid; does not replace culture for susceptibility testing. Benefits: rapid molecular detection compared to traditional culture methods.

Clinical Evidence

Prospective clinical study (n=908) of antepartum women (15-44 years) at four US sites. Compared AmpliVue GBS Assay to bacterial culture. Sensitivity 99.5% (95% CI: 96.9-100%), specificity 92.7% (95% CI: 90.5-94.3%). Discordant analysis performed using an FDA-cleared molecular device.

Technological Characteristics

Isothermal helicase-dependent amplification (HDA) of thiolase (atoB) gene. Manual heat lysis (95°C). Self-contained disposable cassette with vertical-flow DNA detection strip (anti-FITC/anti-DNP antibodies). Visual readout via streptavidin-conjugated color particles. No instrumentation required. Standalone device.

Indications for Use

Indicated for qualitative detection of Group B Streptococcus (GBS) in vaginal/rectal swabs from antepartum women (ages 15-44) after 18-24 hours of LIM enrichment broth culture. Not for point-of-care use; does not provide antibiotic susceptibility.

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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510(k) #: K133503

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.