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 [Todd Hewitt Broth supplemented with colistin (10 µg/mL) and nalidixic acid (15 µg/mL )] or TransVag Broth (Todd-Hewitt broth supplemented with gentamycin (8 µg/ml.) and nalidixic acid (15 ug/mL)].

The illumigene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agoloctioe by targeting a segment of the Streptococcus ogolactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay is not intended to 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.

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

Device Description

The illumicene Molecular Diagnostic Test System is comprised of the illumigene® Group B Streptococcus (GBS) DNA Amplification Test Kit, the illumiqene Group B Streptococcus (GBS) External Control Kit and the illumipro-10 Automated Isothernal Amplification and Detection System.

The illumicene Group B Streptococus (GBS) DNA amplification assay utilizes loog-mediated isothermal amplification (LAMP) technology to detect the presence of Streptococus agatatiae in enriched from vaginal/rectal swab specimens taken from antepartum women. Each illumigene GBS assay is completed using illumigene Reaction Buffer, an illumigene GBS Test Device, and an illumigene Heat Treatment Tube. Samples are diluted with the illumigene Control Reagent, target DNA is made available for isothermal amplification via 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. agalaction is present in the enriched culture sample, a conserved sequence of the S. agalified and magnesium pyrophosphate is formed. Magnesium pyrophosphate in the reaction mixture. The illumipro-10 detects the change in light transmission 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 Streptococus (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 Streptococus External Control Kit is required for routine Quality Control.

AI/ML Overview

Here's an analysis of the illumigene® GBS DNA Amplification Assay's acceptance criteria and the study proving it, based on the provided 510(k) Summary Statement:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the provided document. Instead, the "Performance Comparison, Clinical Tests" section implicitly sets the acceptance criteria through the reported sensitivity and specificity values. The device presumably met the internal criteria by demonstrating these performance characteristics.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Overall)	95% Confidence Interval
Sensitivity	High (e.g., >95%)	97.4%	91.9% - 99.0%
Specificity	High (e.g., >90%)	92.3%	90.0% - 94.1%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 826 qualified patient samples.
Data Provenance: Retrospective and prospective (implied by "clinical trials... were conducted in 2011" and samples were "obtained according to the collection of clinical specimens"). The samples originated from the Midwestern and Southern regions of the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method. It mentions that "Specimens that generated discrepant results were further evaluated by independent testing laboratories using FDA cleared or laboratory validated molecular assays." This suggests an ad-hoc adjudication process for discrepant cases rather than a predetermined expert consensus method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not mentioned. The device is a diagnostic assay, and its performance was compared to bacterial culture, not human expert interpretation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The "Performance Comparison, Clinical Tests" section directly reports the sensitivity and specificity of the illumigene® GBS assay based on its direct application to enriched patient samples, without human interpretation of the assay's output (Positive/Negative).

7. Type of Ground Truth Used

The ground truth used was bacterial culture enrichment followed by bacterial culture with Group B Streptococcus identification. This is explicitly stated as the "Reference comparator."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It describes assay development and analytical sensitivity testing, but not a distinct training set in the context of machine learning. The "Clinical trials" section refers to clinical validation, not training.

9. How the Ground Truth for the Training Set Was Established

As no specific "training set" with established ground truth is detailed in the document, this question cannot be fully answered. However, the overall ground truth method for the clinical validation was bacterial culture enrichment and identification (as noted in point 7). It is reasonable to assume similar methods were used for any internal development or calibration datasets.

Summary

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illumigene® GBS 510(k) Summary Statement

Date of preparation:

K112125: illumiqene® Group B Streptococcus (GBS) DNA Amplification Assay

Attachment 002.002

November 17, 2011

Submitter:	Meridian Bioscience, Inc.
Submitter's address:	3471 River Hills DriveCincinnati, Ohio 45244
Contact:	Michelle Smith
Contact number:	(513) 271-3700
Device name:	illumigene® Group B Streptococcus (GBS)illumigene® Group B Streptococcus (GBS) External Control Kit
Common name:	Streptococcus spp. Serological reagents
Classification name:	Nucleic Acid Amplification Assay System, Group B Streptococcus Direct Specimen TestNJR, CFR Section 866.3740
Predicate device:	K062948: Cepheid® Smart GBSModel SCGBS-100N-50
Reference comparator:	Culture enrichment followed by bacterial culture with Group B Streptococcusidentification

Description:

ldentification:

K112125

Date:

Description of the device:

510(k) number:

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Image: MeridianBioscience, Inc.	K112125: illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
Description:	illumigene® GBS 510(k) Summary Statement
Identification:	Attachment 002.002
Date:	November 17, 2011

Intended Use:

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

The illumicene GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP)2 to detect Streatococcus agaloctiae by targeting a segment of the Streptoccus agalactiae genome. Results from the illumigene GBS assay can be used as an aid in establishing the GBS colonization 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.

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

Comparison to predicate device:

Characteristic	illumigene® GBS	Cepheid® Smart GBS
Test Format	DNA Amplification Assay	DNA Amplification Assay
Intended Use
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 genomeSegment 3	Unique region of the S. agalactiae chromosome
Qualitative/Quantitative	Qualitative	Qualitative
Screening, Diagnostic or IdentificationTest	Diagnostic	Diagnostic
Specimen Types
Vaginal/Rectal Swab Specimen	No	Yes (Direct Method)
Vaginal/Rectal Swab SpecimenEnriched in Lim Broth	Yes	Yes (Enriched Method)
Vaginal/Rectal Swab SpecimenEnriched in TransVag Broth	Yes	No
Reagents/Components	illumigene Control Reagentillumigene Reaction Bufferillumigene GBS Test Deviceillumigene Heat Treatment Tubes	Sample Preparation ReagentTreatment ReagentLysis ReagentMaster MixPositive ControlNegative Control

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	K112125: illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
	Description:	illumigene® GBS 510(k) Summary Statement
	Identification:	Attachment 002.002
	Date:	November 17, 2011

Characteristic	illumigene® GBS	Cepheid® Smart GBS
Extraction	Not applicable. Sample preparation by heattreatment. DNA extraction and purification notrequired.	Self-contained and automated
Amplification	Self-contained and automated	Self-contained and automated
Detection	Self-contained and automated	Self-contained and automated
Testing Time	Approximately 60 minutes	Approximately 75 minutes
Calibration	Not required	Not required
Controls
Inhibition, Assay	Providedillumigene Control Reagent: Non-infectiousPlasmid DNA, S. aureus insertillumigene GBS Test Device, Control Chamber:Staphylococcus aureus LAMP Primers	ProvidedMaster Mix: Internal control DNA templatePositive Control: Internal Control DNA template,non-infectious genomic GBS DNANegative Control: Internal Control DNA template,non-infectious genomic DNA from Streptococcus pneumoniae
External	Adjunct Reagentsillumigene Group B Streptococcus (GBS)External Control Kit, Catalog 279900	User SuppliedKWIK-STIK Cepheid: Smart GBS QC Set fromMicroBioLogics, catalog 8165; one each ofStreptococcus agalactiae low-, moderate- and high-level positive control and L. acidophilus as negativecontrol.User Supplied
Extraction	Not ApplicableSample preparation, including heat treatmentmonitored by external thermometer andinterval timer. Equipment is user supplied.	User Supplied
Equipment
Instrumentation	illumipro-10™ Automated IsothermalAmplification and Detection System	SmartCycler® Dx System
General Laboratory Equipment	Micropipette 50 µL, 200 µLDry-bath with 12 mm heat block, 95 CDigital Thermometer with Max/MinTemperature MemoryInterval TimerVortex Mixer	Vortex Mixer with microtube holderMicrocentrifugeMicropipettors, 5 - 1000 µL rangeCooling Block, 2 - 8 CStopwatch or timer
Reading Method	Visible Light Transmission	Fluorescence

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Image: Meridian Bioscience, Inc. logo	K112125: illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
Description:	illumigene® GBS 510(k) Summary Statement
Identification:	Attachment 002.002
Date:	November 17, 2011

Characteristic	illumigene® GBS	Cepheid® Smart GBS
Results
Group B Streptococcus SerotypesTested	la, Ib, Ic, II, III, IV, V, Vla, VII, VIII, X	la/c, lb/c, II, III. IV, IVc, V, VI, VII, VIII
Results Interpretation	INVALID	POSITIVE
	POSITIVE	NEGATIVE
	NEGATIVE	INVALID
		ND (Not Determined)
		NO RESULT
Performance
Sensitivity	97.4% [95% CI: 91.9% - 99.0%]	98.7% [95% CI: 92.8% - 100.0%]
Specificity	92.3% [95% CI: 90.0% - 94.1%]	90.4% [95% CI: 85.8% - 93.9%]

Performance Comparison, Non-clinical Tests:

Interference Testing

Selected substances that might be expected to be present in vaginal/rectal swab samples taken from antepartum women were were added to a negative Lim broth sample positive Lim broth samples. The negative sample was prepared by pooling confirmed negative Lim Broth samples while samples were prepared by spiking a pooled, confirmed negative Lim sample with either Streptococcus again 11248 Serotype la (123 CFU/test) or Streptococcus agalaction, 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 on to 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.

The following substances, at the specified 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). The following substances do not interfere with test results: Meconium, Stool, Hemorrhoidal cream (30.65 mg/100mg), Miconazole (fungicide), Mucin (0.5-1.5%), Spermicidal gel (nonoxynol 9) (4 mg/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.

Cross-reactivity Study

Potentially cross-reactive microorganisms expected to be present in vaginal/rectal swab specimens were added to negative and contrived positive Lim Broth sample was prepared by pooling confirmed negative Lim Broth samples. The contrived positive sample was prepared by spiking a confirmed negative matrix with Streptococcus agaloctioe, 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 10° CFU/mL (bacteria and fung) or virus at a minimum of 1 x 10° TCIDss/mL (viruses). 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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Image: MeridianBioscience, Inc. logo	K112125: illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
	Description:	illumigene® GBS 510(k) Summary Statement
	Identification:	Attachment 002.002
	Date:	November 17, 2011

The following microorganisms at the indicated concentrations do not interfere with illumigene GBS: Aeromonas hydrophilo, Alcaligenes faecalis, Bacillus cereus, Bacilis, Bacteroides fragilis, Campylobacter fetus, Campylobacter jejuni, Candida albicans, Candida krusei, Candida parapsilosis, Candida tropicalis, Citrobacter freundii, Clostridium bifermentans, Clostridium bifficile, Clostridium histolyticum, Clostridium novy, Clostridium perfringens, Clostridium septicum, Clostridium sporogenes, Clostridium tetani, Corynebacterium genitalium, Connebatterium urealyticum, Corynebacter aerogenes, Enterobacter cloacae, Enterococus avium, Enterococus durans, Enterococus faecalis, Enterococus faecium, Escherichia coli 0157:H7, Escherichia fergusonii, Escherichia hermannii, Gardnerella vagindus ducrey, Helicobacter pylori, Klebsiella pneumoniae, Loctobacillus acidophilus, Loctobacillus brevis, Lactobacillus delbruekii subspecies lactis, Lactobacillus jensenii, Lactococcus lactis, Legionella pneumophila, Listeria morocytogenes, Morganella morganii, Neisseria gonorrhoeve, Peptostreplococus anaerobius, Plesionomas shigelloides, Porphyromonas asaccharolytica, Prevotella meianinogenica, Propionibacterium acnes, Proteus vulgaris, Pseudomonas aeruginosa, Pseudomonus fluorescens, Salmonella Group B, Salmonella Group C, Salmonella Group E, Serratia liquefaciens, Seratia marcescens, Shigella boydi, Shigella flexneri, Shigella sonnei, Staphylococus aureus (Cowan), Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococus anginosus, Streptococus dysgolactiae equisimilis, Streptococus intermedius, Streptococcus mitis, Streptococcus oralis, Streptococcus pyogenes, Streptococus solivarius, Streptococcus sanguinis, Vibrio parahaemolyticus, Versinia enterocolitica, Adenovirus 41, BK virus, Coxschievirus, Echovirus, Epstein Barr virus, Herpes Simplex Virus-1, Herpes Simplex Virus-2, Rotavirus.

Mycoplasma genitalium, Mycoplasma hominis and Ureaplasma uredyticum were tested at final concentrations ranging between 1.6 x 10° and 9.9 x 10° CFU/mL with no reaction with the illumigene GBS assay.

Performance Comparison, Clinical Tests:

Clinical trials for the illumigene Group (GBS) assay, including the Mumipro-10 Automated Isothermal amplification and detection system, were conducted in 2011. Performance characteristics of the illumione 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 were obtained according to the collection of clinical specimens for culture of Group B Streptococus and enriched for 18-24 hours in either Lim Broth or TransVag Broth prior to illumigene testing. Four hundred three (403, 48.8%) specimens were enriched with Lim Broth and 423 (51.2%) speciment 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 3 (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% Cl: 91.9% - 99.0%) where Specificity is 92.3% [95% C: 90.0% - 94.1%]. Table 1 shows assay shows overall assay performance, including evaluation by enrichment medium; Table 2 summarizes assay performance by Clinical Site.

SampleType	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%	296/315	94.0%	90.8 - 96.1%
TransVag	68/70	97.1%	90.2 - 99.2%	314/346	90.8%	87.2 - 93.4%

Table 1: Performance characteristics summary

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Image: Meridian Bioscience, Inc. logo	K112125: illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
Description:	illumigene® GBS 510(k) Summary Statement
Identification:	Attachment 002.002
Date:	November 17, 2011

Table 2: Performance characteristics summary

SiteIdentification	EnrichmentBroth	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 3	TransVag	36/37	97.3%	86.2 - 99.5%	117/147	79.6%	72.4 - 85.3%
Site 2	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%	85.5 - 94.8%

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 or laboratory validated molecular assays. Sixteen of nineteen Lim Broth False Positive by an alternate molecular method. All thity-two TransVag Broth False Positive by an alternate molecular method. In addition to discrepant sample analysis, a selection of concordant samples was tested with non-illumigene molecular methodogies. Concordant result testing showed a combined correlation between molecular methods of 97.7%.

Analytical Sensitivity

The analytical sensitivity of the illumigene Group B Streptococcus (GBS) assay was determined for six common S. ogdaction strains representing six serotypes. Analytical sensitivity is based on a minimum of 20 replicates for each measurand with a stated probability (eg, 95% where 19/20 replicates are positive responses. Analytical sensitivity testing is summarized below:

Serotype	Streptococcus agalactiae Strain Description	CFU/Test
Ia	NCTC 11248	60
Ib	ATCC 12401	80
Ic	NCTC 11253	640
II	II/2	320
III	ATCC 12403	160
V	ATCC BAA-611	1280

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 V: NCTC 08188; Serotype VII: VII/2; Serotype VIII: VII/2; Serotype X: NCTC 11249; Unknown Serotype: ATCC 13813 and ATCC12386.

Reproducibility

Blind coded panels of 10 samples were supplied to three independent laboratories for reproducibility studies. Samples were randomly sorted within each panel to mask sample identived samples manufactured as low positive samples (i.e. limit of detection, 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-assy 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:

{6}------------------------------------------------

Image: MeridianBioscience, Inc.	K112125: illumigene® Group B Streptococcus (GBS) DNA Amplification Assay
	Description:	illumigene® GBS 510(k) Summary Statement
	Identification:	Attachment 002.002
	Date:	November 17, 2011

	Site 1		Site 2		Site 4		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%

Conclusions

The illumigene Group B Streptococus (GBS) assay, used in conjunction with the illumipro-10, can be used to detect Streptococcus agalactiae in vaginal/rectal specimens taken women following culture enrichment in either Lim Broth or TransVag Broth. The test is diagnostic for Group B Streptococcus.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird-like figure with three curved lines forming its body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Meridian Bioscience, Inc. c/o Susan D. Rolih Director Quality Systems 3471 River Hills Drive Cincinnati, OH 45244

DEC - 5 2011

Re: K112125

Trade/Device Name: illumigene ® Group B Streptococcus (GBS) DNA Amplification Assay Regulation Number: 21 CFR § 866.3740 Regulation Name: Nucleic acid amplification assay system Regulatory Class: Class I Product Codes: NJR Dated: November 17, 2011 Received: November 18, 2011

Dear Ms. Rolih:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Paris 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2) CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vayattom

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Devices Evaluation and Safety Center for Devices and Radiological Health

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Indication(s) for Use Form

510(k) Number (if known): K112125

Device Name: illumigene Group B Streptococcus (GBS) DNA Amplification Assay

Indications for Use:

The illumigene GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

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

AND/OR

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 ANOTHER PAGE OF NEEDED)

oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie Lee Poole

vision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112125

Regulation Number and Section

§ 866.3740

Streptococcus spp. serological reagents.(a)
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 identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.