ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT

K112125 · Meridian Bioscience, Inc. · NJR · Dec 5, 2011 · Microbiology

Device Facts

• Record ID: K112125
• Device Name: ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
• Applicant: Meridian Bioscience, Inc.
• Product Code: NJR · Microbiology
• Decision Date: Dec 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3740
• Device Class: Class 1

Indications for Use

The illumigene® Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth or TransVag Broth. The illumigene® GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene® GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The illumigene® GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. The illumigene® Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

Device Story

System detects Streptococcus agalactiae in enriched vaginal/rectal swab cultures; utilizes loop-mediated isothermal DNA amplification (LAMP) technology. Input: enriched culture sample; process: illumipro-10™ heats test device to amplify target genome segment; magnesium pyrophosphate precipitate forms during amplification; output: change in light transmission detected by illumipro-10™; results reported as Positive or Negative. Used in hospital, reference, or state laboratories; operated by laboratory personnel. Output aids in establishing GBS colonization status; does not diagnose infection or provide susceptibility data. Benefits: rapid, automated molecular detection of GBS colonization.

Clinical Evidence

Clinical study evaluated 826 patient samples across four sites. Comparison to bacterial culture showed 97.4% sensitivity (95% CI: 91.9-99.0%) and 92.3% specificity (95% CI: 90.0-94.1%). Discrepant analysis using alternate molecular methods showed high correlation (97.7%).

Technological Characteristics

LAMP-based isothermal DNA amplification. Instrumentation: illumipro-10™ Automated Isothermal Amplification and Detection System. Detection principle: turbidity/light transmission change due to magnesium pyrophosphate precipitation. Sample matrix: Lim or TransVag broth enriched vaginal/rectal swabs. Connectivity: standalone instrument. Sterilization: not specified.

Indications for Use

Indicated for qualitative detection of Streptococcus agalactiae in enriched vaginal/rectal swab specimens from antepartum women to aid in establishing GBS colonization status. Not for diagnosing/monitoring GBS infections or providing susceptibility results.

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.

Predicate Devices

• Cepheid® Smart GBS, Model SCGBS-100N-50 (K062948)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE

A. 510(k) Number:
K112125

B. Purpose for Submission:
To determine substantial equivalence for the illumigene® Group B Streptococcus (GBS) DNA Amplification Assay used for the qualitative detection of Streptococcus agalactiae.

C. Measurand:
Segment of the Streptococcus agalactiae genome

D. Type of Test:
Qualitative in vitro diagnostic using Loop-mediated isothermal DNA amplification (LAMP) technology

E. Applicant:
Meridian Bioscience, Inc.

F. Proprietary and Established Names:
illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
illumigene® Group B Streptococcus (GBS) External Control Kit

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NJR, Nucleic acid amplification assay system, Streptococcus spp., serological reagents | Class I | 21 CFR § 866.3740 | Microbiology (83) |

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H. Intended Use:

g. Intended use:

The illumigene® Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth or TransVag Broth.

The illumigene® GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene® GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The illumigene® GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The illumigene® Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

2. Indications for use:

The illumigene® Group B Streptococcus (GBS) assay, performed on the illumipro-10, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth or TransVag Broth.

The illumigene® GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the illumigene® GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections. The illumigene® GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The illumigene® Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for point-of-care use.

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3. Special conditions for use statement(s):
- For Prescription Use Only
- The device is not intended for point-of-care use

4. Special instrument requirements:
illumipro-10™ Automated Isothermal Amplification and Detection System

I. Device Description:

The illumigene® Molecular Diagnostic Test System is comprised of the illumigene® Group B Streptococcus (GBS) DNA Amplification Test Kit, the illumigene® Group B Streptococcus (GBS) External Control Kit and the illumipro-10™ Automated Isothermal Amplification and Detection System. The illumigene® Group B Streptococcus (GBS) DNA amplification assay utilizes loop-mediated isothermal amplification (LAMP) technology to detect the presence of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens taken from antepartum women. Each illumigene® GBS assay is completed using illumigene® Control Reagent, illumigene® Reaction Buffer, an illumigene® GBS Test Device and an illumigene® Heat Treatment Tube. Samples are diluted with the illumigene® control heat-treatment in the illumigene® Heat Treatment Tube and DNA amplification occurs in the illumigene® GBS Test Device.

The illumipro-10™ heats each illumigene® GBS Test Device containing prepared samples and Control Reagent, facilitating amplification of target DNA. When S. agalactiae is present in the enriched culture sample, a conserved sequence of the S. agalactiae is amplified and magnesium pyrophosphate is formed. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro-10™ detects the change in light transmission through the reaction mixture created by the precipitating magnesium pyrophosphate. Sample results are reported as Positive or Negative based on the detected change in light transmission.

The illumigene® Group B Streptococcus (GBS) External Control Kit consists of a Positive Control Reagent and a Negative Control Reagent. External Control reagents are provided to aid the user in detection of reagent deterioration, adverse environmental or test conditions, or variance in operator performance that may lead to test errors. The illumigene® Group B Streptococcus External Control Kit is required for routine Quality Control.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Cepheid® Smart GBS, Model SCGBS-100N-50

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2. Predicate 510(k) numbers:

K062948

3. Comparison with predicates:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | K112125 | K062948 |
| Intended Use | Qualitative | Same |
| Test Principle | DNA Amplification Assay | Same |
| Specimen Types | Vaginal/Rectal Swab Specimen Enriched in Lim Broth | Same |
| Amplification | Self contained and automated | Same |
| Detection | Self contained and automated | Same |
| Calibration | Not required | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | K112125 | K062948 |
| Specimen Types | Vaginal/Rectal Swab Specimen Enriched in TransVag Broth | Vaginal/Rectal Swab Specimen |
| Reading Time | 60 minutes | 75 minutes |
| DNA Amplification Technology | Loop-Mediated Isothermal Amplification (LAMP) | Real-Time Polymerase Chain Reaction (PCR) |
| Target Sequences Detected | 213 base pair (bp) sequence residing in the 593-805 bp region of S. agalactiae genome Segment 3 | Unique region of the S. agalactiae chromosome |
| Reagents | illumigene® Control Reagent illumigene® Reaction Buffer illumigene® GBS Test Device illumigene® Heat Treatment Tubes | Sample Preparation Reagent Treatment Reagent Lysis Reagent Master Mix Positive Control Negative Control |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | K112125 | K062948 |
| Instrumentation | Illumipro-10™ Automated Isothermal Amplification and Detection System | SmartCycler® Dx System |
| Reading Method | Visible Light Transmission | Fluorescence |
| Performance: • Sensitivity • Specificity | 97.4% [95% CI: 91.9% - 99.0%] 92.3% [95% CI: 90.0% - 94.1%] | 98.7% [95% CI: 92.8% - 100.0%] 90.4% [95% CI: 85.8% - 93.9%] |

# K. Standard/Guidance Document Referenced (if applicable):

Clinical and Laboratory Standards Institute. 2008. User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition (EP12-A2)

Clinical and Laboratory Standards Institute. 2005. User Verification of Performance for Precision and Trueness; Approved Guideline—Second Edition (EP15-A2)

Clinical and Laboratory Standards Institute. 2005. Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition (EP7-A2)

# L. Test Principle:

The illumigene® Group B Streptococcus (GBS) Assay is based on loop-mediated isothermal amplification technology (LAMP). Loop-mediated amplification is accomplished by the use of specially designed primers that provide specific and continuous isothermal DNA amplification. Magnesium-pyrophosphate is produced as a by-product of LAMP amplification. The magnesium-pyrophosphate forms a white precipitate in the reaction solution, giving the reaction solution a turbid appearance. The presence of turbidity signifies a positive reaction while the absence of turbidity represents a negative reaction.

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M. Performance Characteristics:

1. Analytical performance:

a. Precision/Reproducibility:

For Meridian’s reproducibility studies, blind coded panels of 10 samples were supplied to three independent laboratories. Samples were randomly sorted within each panel to mask sample identities. The panels included contrived samples manufactured near the assay limit of detection (i.e., low positive samples), n = 3 and high negative samples, n = 3. The panels also included contrived positive (n = 3) samples and natural negative samples (n = 1). Testing was performed by different operators at each site on the same day (intra-assay variability) for five days (inter-assay variability). Three lots of illumigene GBS and five illumipro-10™ instruments were used in this study. The results are given in the table below:

| | Site 1 | | Site 2 | | Site 3 | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample Type | Percent agreement | | Percent agreement | | Percent agreement | | Percent agreement | |
| Negative | 10/10 | 100% | 10/10 | 100% | 10/10 | 100% | 30/30 | 100% |
| High Negative | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 90/90 | 100% |
| Low Positive | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 90/90 | 100% |
| Positive | 30/30 | 100% | 30/30 | 100% | 30/30 | 100% | 90/90 | 100% |

Reproducibility studies are acceptable.

b. Linearity/assay reportable range:

Not applicable as this assay is qualitative

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

Stability:

Sample storage and hold time studies were performed to characterize illumigene® Group B Streptococcus assay ranges. Validation studies performed at Meridian indicated that Lim broth represented the worst-case matrix; therefore all samples except two were prepared from enriched Lim medium. The latter two samples (one high negative and one LoD positive sample) were prepared from TransVag broth. Results demonstrated that undiluted samples can be held at 19-27°C for up to 6 hours or at 2-8°C for up to 7 days after culture enrichment and prior to testing. Samples diluted with illumigene® Control Reagent can be held at room temperature

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for up to 15 minutes prior to heat-treatment. Heat-treated samples can be held at room temperature for up to 45 minutes prior to further processing.

Sample freeze/thaw studies were also performed. Samples were enriched 18-24 hours in enrichment broth and frozen prior to initiation of testing, then exposed to multiple freeze/thaw cycles. Results demonstrated that freeze/thaw of samples should not be done.

Final testing demonstrated that Lim Broth in combination with Dacron/polyester, flocked nylon, and foam swab types perform acceptably with the illumigene® GBS assay. The Amies Clear swab type has been identified in the Limitations section of the Package Insert as an incompatible swab type with the illumigene® GBS assay.

d. Detection limit:

Sensitivity studies were designed to determine the analytical limit of detection of S. agalactiae diluted in Lim broth. Six common strains of S. agalactiae, representing six different serotypes, were evaluated using the illumigene® GBS assay. Each strain was spiked into negative Lim broth and then diluted serially. A minimum of twenty replicates of each dilution were individually processed and tested to establish LoD. Testing was performed using three production lots of illumigene® GBS and six illumipro-10™ instruments. External Positive and Negative Controls were tested each day throughout the study.

The LoD of the assay ranged from 60 CFU/Test to 1280 CFU/Test. The table below shows the lowest concentration for each serotype that produced positive results for 95% of the replicates tested.

| Serotype | Streptococcus agalactiae Strain Description | CFU/Test |
| --- | --- | --- |
| 1a | NCTC 11248 | 60 |
| 1b | ATCC 12401 | 80 |
| 1c | NCTC 11253 | 640 |
| II | II/2 | 320 |
| III | ATCC 12403 | 160 |
| V | ATCC BAA | 611 |

Additional S. agalactiae strains were tested and produced positive reactions at 1280 CFU/test with illumigene® GBS. Strains and serotypes were tested as follows: Serotype IV: NCTC 11930; Serotype VIa: NCTC 08188; Serotype VII: VII/2; Serotype VIII: VIII/2; Serotype X: NCTC 11249; Unknown Serotype: ATCC 13813 and ATCC12386.

LoD studies are acceptable.

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e. Analytical specificity:

Interference Testing:

Selected substances that might be expected to be present in vaginal/rectal swab samples taken from antepartum women were added to a negative Lim broth sample and two contrived positive Lim broth samples. The negative sample was prepared by pooling confirmed negative Lim Broth samples while the contrived positive samples were prepared by spiking a pooled, confirmed negative Lim sample with either Streptococcus agalactiae, strain 11248 Serotype Ia (123 CFU/test) or Streptococcus agalactiae, strain 12401 Serotype Ib (80 CFU/test). Potentially interfering substances were added to Lim broth samples at final concentrations of 2.5% v/v or greater when the substances could be pipetted. Substances that could not be pipetted were coated onto cotton swabs, immersed in the negative/positive Lim broth samples and tested. Dilution Controls were prepared by adding a phosphate buffered saline solution in place of the potentially cross-reactive organisms. Each inoculated sample was tested in triplicate.

Results demonstrated that the following substances, at the specified saturated solvent/diluents concentrations, do not interfere with illumigene® Group B Streptococcus test results: Amniotic fluid (10% v/v), Human DNA (100 ng/Test), Urine (30% v/v), Whole Blood (2.5% v/v), Meconium, Stool, Hemorrhoid cream (30.65 mg/100mg), Miconazole (fungicide), Mucin (0.5-1.5%), Spermicidal gel (nonoxynol 9) (4mg/100mg). Lubricating gel produced False Negative Results in 1 of 11 replicates tested. Body Powder produced False Negative Results in 1 of 10 replicates tested. Whole Blood at concentrations greater than 2.5% v/v interferes with the illumigene® GBS assay.

Interference studies are acceptable.

Cross-reactivity Study:

Microorganisms that could potentially cross-react, expected to be present in vaginal/rectal swab specimens were added to negative and contrived positive Lim Broth samples. The negative sample was prepared by pooling confirmed negative Lim Broth samples. The contrived positive sample was prepared by spiking a confirmed negative matrix with Streptococcus agalactiae, strain 12401, at 122 CFU/test, near the limit of detection for this strain. Potentially cross-reactive microorganisms were added at concentrations of 1.2 x 10⁸ CFU/mL (bacteria and fungi) and virus at a minimum of 1 x 10⁵ TCID₅₀/mL. Dilution controls for each sample were prepared by adding sterile saline solution in place of the potentially cross-reactive microorganisms. Each sample was tested in triplicate. Cross-reactivity with Enterococcus dispar was observed in one of seven replicates tested.

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Results demonstrated that the following microorganisms at the indicated concentrations do not interfere with the illumigene® GBS assay: Aeromonas hydrophila, Alcaligenes faecalis, Bacillus cereus, Bacillus subtilis, Bacteroides fragilis, Campylobacter coli, Campylobacter fetus, Campylobacter jejuni, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Citrobacter freundii, Clostridium bifermentans, Clostridium butyricum, Clostridium difficile, Clostridium histolyticum, Clostridium novyi, Clostridium perfringens, Clostridium septicum, Clostridium sordellii, Clostridium sporogenes, Clostridium tetani, Corynebacterium genitalium, Corynebacterium urealyticum, Corynebacterium xerosis, Enterobacter aerogenes, Enterobacter cloacae, Enterococcus avium, Enterococcus durans, Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Escherichia coli 0157:H7, Escherichia fergusonii, Escherichia hermannii, Gardnerella vaginalis, Haemophilus ducreyi, Helicobacter pylori, Klebsiella pneumoniae, Lactobacillus acidophilus, Lactobacillus brevis, Lactobacillus casei, Lactobacillus delbruekii subspecies lactis, Lactobacillus jensenii, Lactococcus lactis, Legionella pneumophila, Listeria monocytogenes, Moraxella osloensis, Morganella morganii, Neisseria gonorrhoeae, Peptostreptococcus anaerobius, Plesiomonas shigelloides, Porphyromonas asaccharolytica, Prevotella melaninogenica, Propionibacterium acnes, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonas fluorescens, Salmonella Group B, Salmonella Group C, Salmonella Group D, Salmonella Group E, Serratia liquefaciens, Serratia marcescens, Shigella boydii, Shigella flexneri, Shigella sonnei, Staphylococcus aureus, Staphylococcus aureus (Cowan), Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus anginosus, Streptococcus bovis, Streptococcus dysgalactiae equisimilis, Streptococcus intermedius, Streptococcus mitis, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus salivarius, Streptococcus sanguinis, Vibrio parahaemolyticus, Yersinia enterocolitica, Adenovirus 40, Adenovirus 41, BK virus, Coxsackievirus, Echovirus, Epstein Barr virus, Herpes Simplex Virus-1, Herpes Simplex Virus-2, Rotavirus, Mycoplasma genitalium, Mycoplasma hominis and Ureaplasma urealyticum were tested at final concentrations ranging between $1.6 \times 10^{6}$ and $9.9 \times 10^{6}$ CFU/mL with no reaction with the illumigene® GBS assay.

Cross reactivity studies are acceptable.

2. Comparison studies:

a. Method Comparison with Predicate:

Not applicable

b. Matrix comparison:

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Not applicable

## 3. Clinical Studies:

### a. Clinical Sensitivity:

Clinical trials for the illumigene® Group B Streptococcus (GBS) assay, including the illumipro™-10 Automated Isothermal amplification and detection system, were conducted. Performance characteristics of the illumigene® GBS assay were determined by comparison to GBS bacterial culture. Four independent clinical test sites located in the Midwestern and Southern regions of the United States evaluated a total of 826 qualified patient samples. Samples were obtained according to established guidelines for the collection of clinical specimens for culture of Group B Streptococcus and enriched for 18-24 hours in either Lim Broth or TransVag Broth prior to illumigene® testing. Four hundred and three (48.8%) specimens were enriched with Lim Broth and 423 (51.2%) specimens were enriched with TransVag Broth prior to testing. The age groups of patients tested ranged from 15 years of age to 44 years of age, with age unknown for three (0.4%) of the patient population. No differences in test performance were observed based on enrichment medium or patient age. Overall assay Sensitivity is reported as 97.4% [95% CI: 91.9% - 99.0%] where Specificity is 92.3% [95% CI: 90.0% - 94.1%].

The table below shows overall assay performance, including evaluation by enrichment medium.

| Sample Type | Positive Samples | | | Negative Samples | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Illumigene® /culture | % Sensitivity | 95% CI | Illumigene® /culture | % Specificity | 95% CI |
| Total | 150/154 | 97.4 | 91.9-99.0 | 610/661 | 92.3 | 90.0-94.1 |
| LIM | 82/84 | 97.6 | 91.7-99.3 | 296/313 | 94.0 | 90.8-96.1 |
| TransVag | 68/70 | 97.1 | 90.2 | 314/346 | 90.8 | 87.2-93.4 |

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The following table summarizes assay performance by Clinical site:

| Site Identification | Enrichment Broth | Positive Samples | | | Negative Samples | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Illumigene® /culture | % Sensitivity | 95% CI | Illumigene® /culture | % Specificity | 95% CI |
| Site 1 | TransVag | 32/33 | 97.0 | 84.7-99.5 | 197/199 | 99.0 | 96.4-99.7 |
| Site 2 | TransVag | 36/37 | 97.3 | 86.2-99.5 | 117/147 | 79.6 | 72.4-85.3 |
| Site 3 | LIM | 38/39 | 97.4 | 86.8-99.5 | 162/168 | 96.4 | 92.4-98.4 |
| Site 4 | LIM | 44/45 | 97.8 | 88.4-99.6 | 134/147 | 97.8 | 92.4-98.4 |

Invalid results were obtained for 11/826 samples tested or 1.3%. Two of the 11 samples remained invalid after repeat testing of the original sample. Specimens that generated discrepant results were further evaluated by independent testing laboratories using FDA cleared molecular assays. Sixteen of nineteen Lim Broth False Positive results were positive by an alternate molecular method. All thirty-two TransVag Broth False Positive results were positive by an alternate molecular method. In addition to discrepant sample analysis, a selection of concordant samples was tested with non-illumigene® molecular methodologies. Concordant result testing showed a combined correlation between molecular methods of 97.7%. Results from discrepant analysis were not used to calculate Sensitivity and Specificity.

Clinical studies are acceptable.

b. Clinical Specificity

See Section 3a

c. Other Clinical Supportive data

Not applicable

4. Clinical cut-off:

Not Applicable

5. Expected Values/Reference Range:

Approximately 10-30% of antepartum women are colonized with Group B Streptococcus in the vagina or rectum. The overall incidence of GBS colonization in antepartum women tested during this study was 24.3% (201 of 826). Incidence of GBS colonization for enrichment performed using Lim Broth was found to be 25.1% (101 of 403); while incidence for specimens enriched by TransVag Broth was found to be 23.6% (100 of 423).

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N. Instrument Name

illumipro-10™

O. System Descriptions:

System Description was reviewed in previous submission, K100818 and K110012. No systems or software changes were made.

1. Modes of Operation:

The illumipro™-10 heats each illumigene® GBS Test Device containing prepared samples and Control Reagent, facilitating amplification of target DNA. When S. agalactiae is present in the enriched culture sample, a conserved sequence of the S. agalactiae is amplified and magnesium pyrophosphate is formed. Magnesium pyrophosphate forms a precipitate in the reaction mixture. The illumipro™-10 detects the change in light transmission through the reaction mixture created by the precipitating magnesium pyrophosphate. Sample results are reported as Positive or Negative based on the detected change in light transmission.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☑ or No ☐

3. Specimen Identification:

The illumipro-10™ utilizes software to automate incubation and detection of illumigene Molecular Diagnostic in vitro diagnostic test reactions. The illumipro-10™ reports sample results as INVALID, POSITIVE or NEGATIVE

4. Specimen Sampling and Handling:

Specimens are prepared manually. Incubation and detection are automated using the illumipro-10™

5. Calibration:

Calibration of the illumipro-10 is not required.

6. Quality Control:

The illumigene® Group B Streptococcus (GBS) External Control Kit consists of a Positive Control Reagent and a Negative Control Reagent. External Control reagents are provided to aid the user in detection of reagent deterioration, adverse

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environmental or test conditions, or variance in operator performance that may lead to test errors. The illumigene® Group B Streptococcus External Control Kit is required for routine Quality Control.

P. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10

Q. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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