(116 days)
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. The assay consists of Test Strips containing anti-Legionella pneumophila serogroup 1 as the capture antibody, Containing anti-Legionella pneumophila serogroup 1 as the detection antibody, Sample Diluent/Negative Control, and Positive Control.
The provided text describes the performance of the TRU Legionella assay, an in vitro rapid lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. The study aims to demonstrate substantial equivalence to a predicate device, the BinaxNOW® Legionella Urinary Antigen test.
Here's an analysis based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for positive or negative agreement. Instead, it presents the performance of the TRU Legionella assay in comparison to the predicate device, the BinaxNOW® Legionella test, and demonstrates high correlation. The overall performance metrics serve as the reported device performance.
| Performance Metric | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (TRU Legionella) |
|---|---|---|
| Positive Agreement | High agreement with BinaxNOW® Legionella | 96.3% (95% CI: 91.7 - 98.4%) |
| Negative Agreement | High agreement with BinaxNOW® Legionella | 100.0% (95% CI: 98.7 - 100.0%) |
| Overall Correlation | High correlation with BinaxNOW® Legionella | 98.8% (95% CI: 97.3 - 99.5%) |
| Reproducibility (Overall) | High correlation between expected and achieved results | 100% (98.7 - 100.0%) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 428 qualified patient samples.
- Data Provenance:
- Country of Origin: Southeastern regions of the United States and the Netherlands.
- Retrospective/Prospective: The US clinical trial sites evaluated both retrospective frozen samples and prospectively collected samples. The retrospective samples were those previously submitted for Legionella testing. The site in the Netherlands evaluated 220 frozen samples from a well-characterized repository.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the clinical study was established by comparison to the Binax NOW® Legionella Urinary Antigen test (predicate device). The document does not describe the use of independent experts to establish ground truth for this comparison study, as it's a comparative effectiveness study against a legally marketed device. The predicate device itself serves as the reference standard for "truth" in this context.
For the samples from the Netherlands, they were "chosen from a well characterized repository of urine samples collected from patients with confirmed Legionnaires Disease as well as negative specimens from patients suspected of infection by Legionella," implying an existing clinical diagnosis. However, the exact number and qualifications of experts involved in the initial confirmation of these Legionnaires' Disease cases are not specified in this document.
4. Adjudication Method for the Test Set
Not applicable. The study is a direct comparison of the TRU Legionella assay's results against the BinaxNOW® Legionella test. There is no mention of an adjudication method involving multiple readers or experts to resolve discrepancies between the two tests. The BinaxNOW® result is treated as the reference.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed to assess human reader improvement with AI assistance. This document describes the performance of an in vitro diagnostic (IVD) rapid immunoassay, not an AI-powered diagnostic imaging or interpretation tool. The test is visually read by a single operator, and the comparison is between the new device and a predicate device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this is effectively a standalone performance study. The TRU Legionella assay is an in vitro rapid lateral-flow immunoassay designed for direct visual interpretation of results. Its performance is measured independently against the predicate device without human-in-the-loop assistance for the assay itself (beyond the visual reading as intended).
7. Type of Ground Truth Used
The primary ground truth used for the clinical performance comparison was the results from the predicate device, BinaxNOW® Legionella Urinary Antigen test. For the samples from the Netherlands, the repository samples were "from patients with confirmed Legionnaires Disease," suggesting clinical diagnosis/outcomes data for positive cases, and "negative specimens from patients suspected of infection by Legionella" for negative cases.
8. Sample Size for the Training Set
The document does not explicitly describe a separate "training set" in the context of machine learning or AI development. This is a traditional IVD device. The analytical studies (sensitivity, interference, cross-reactivity, strain reactivity) involve testing numerous laboratory-prepared specimens, but these are for analytical validation rather than AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a traditional IVD device and not an AI-based system involving a training set in the machine learning sense. The analytical studies establishing limits of detection, interference, and cross-reactivity use known concentrations of L. pneumophila strains or other substances, which are internally controlled ground truths established through laboratory methods.
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FEB 2 4 2012
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a mix of letters and numbers. The string starts with a letter 'K', followed by two instances of the number '1', then the number '3', another '1', the number '9', and ends with the letter 'O'. The handwriting is somewhat cursive, with the numbers and letters connected.
Image /page/0/Picture/2 description: The image shows the logo for Meridian Bioscience, Inc. The logo features a globe graphic on the left, followed by the word "Meridian" in a bold, italicized font. Below the word "Meridian" is a horizontal line, and below that is the text "Bioscience, Inc." in a smaller, italicized font.
| 510(k) Application TRU Legionella | |
|---|---|
| Description: | 510(k) Summary |
| Identification: | Attachment 002 |
| Date: | October 28, 2011 |
510(k) number:
Date of Preparation: October 28, 2011
| Submitter: | Meridian Bioscience, Inc |
|---|---|
| Submitter's address: | 3471 River Hills DriveCincinnati, Ohio 45244 |
| Contact: | Susan Bogar |
| Contact number: | (513) 271-3700 |
| Device name: | TRU Legionella |
| Common name: | Device Legionella, Spp., Elisa |
| Classification: | Haemophilus spp serological reagentsMJH, CFR Section 866.3300 |
| Predicate device: | K982238: Binax NOW® Legionella |
| Reference comparator: | Binax NOW® Legionella |
Description of the Device
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. The assay consists of Test Strips containing anti-Legionella pneumophila serogroup 1 as the capture antibody, Containing anti-Legionella pneumophila serogroup 1 as the detection antibody, Sample Diluent/Negative Control, and Positive Control.
Intended Use
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
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| 510(k) Application TRU Legionella | |||
|---|---|---|---|
| Description: | 510(k) Summary | ||
| Identification: | Attachment 002 | ||
| Date: | October 28, 2011 |
Table 1: Comparison to Predicate Device
| Characteristic | TRU Legionella | BinaxNOW® Legionella |
|---|---|---|
| Test Format | Rapid lateral flow immunoassay | Rapid immunochromatographic membraneassay |
| Intended Use | ||
| Qualitative/Quantitative | Qualitative | Qualitative |
| Target Antigen | Legionella pneumophila serogroup 1 | Legionella pneumophila serogroup 1 |
| Specimen Types | Human urine, preserved and unpreserved | Human urine, preserved and unpreserved |
| Reagents/Components | Test StripConjugate TubeSample Diluent/Negative ControlPositive ControlPlastic transfer pipettes with 100, 200 and300 µL volume marks | Test DeviceReagent APositive Control SwabNegative Control SwabSwabs |
| Antibody Sources | ||
| Test Card | Rabbit polyclonal | Rabbit polyclonal |
| Conjugate | Rabbit polyclonal | Polyclonal |
| Sample Preparation | ||
| Unpreserved and preserved urine | 1. Add 100 µl of Sample Diluent toConjugate Tube. Vortex for 10 seconds.2. Add 100 µl of thoroughly mixed urinesample to the Conjugate Tube.3. Mix sample and conjugate thoroughly. | 1. Dip swab into the urine sample and theninsert swab into the bottom hole of the TestDevice.2. Add 2 drops of Reagent A to the bottomhole. |
| Testing Time | Approximately 20 minutes | Approximately 15 minutes |
| Equipment | ||
| General Laboratory Equipment | VortexInterval timerDisposable latex gloves | TimerUrine collection containerBinaxNOW® Legionella Urinary AntigenControl Swab Pack |
| Reading Method | Visual | Visual |
| Results Interpretation | ||
| Visual Read | Negative: A PINK-RED band at the ControlLine position. No other bands are present.Positive: PINK-RED band of any colorintensity at the Control and Legionella TestLine positions.Invalid: No band at the Control Lineposition, a pink-red band appearing after21 minutes of incubation, or a band of anyother color than pink-red. | Negative: Single pink to purple coloredControl line visible in the top half of thewindow.Positive: Two pink to purple colored lines.Invalid: No line at the Control Line positionor no lines at the Control or Sample Linepositions. |
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Image /page/2/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo features a globe-like icon on the left, followed by the word "Meridian" in a bold, italicized font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, non-italicized font. A horizontal line separates "Meridian" from "Bioscience, Inc."
| 510(k) Application TRU Legionella | |||
|---|---|---|---|
| Description: | 510(k) Summary | ||
| Identification: | Attachment 002 | ||
| Date: | October 28, 2011 |
Performance Comparison, Non-Clinical Tests Analytical Sensitivity
Sensitivity studies were designed to determine with 95% confidence the analytical limit of detection (LoD) of L. pneumophila Philadelphia and Bellingham strains diluted in a human urine matrix. The analytical sensitivity of this assay was based on 45 replicates for each measurand and with a stated probability (95%) of obtaining positive responses at the following levels of the measurand shown in Table 1.
Table 2: Analytical Sensitivity
| Strain ID | Limit of Detection (LoD) |
|---|---|
| Philadelphia strain (Pontiac subgroup; ATCC 33152) | $3.76 x 10^5$ CFU/mL |
| Bellingham strain (non-Pontiac subgroup; NCTC 11404) | $5.2 x 10^5$ CFU/mL |
Interference Testing
Selected drugs and other non-microbial substances that might be present in urine samples from healthy persons or patients suspected of having L. pneumophila infection were added to three natural negative and three contrived positive samples. The contrived positive samples were prepared by spiking confirmed negative samples with Legionella pneumophila Philadelphia strain antigen at 3.76 x 10 CFU/mL, the limit of detection for this assay. Dilution Controls for each sample were prepared by adding a saline solution in place of the potentially interfering substance.
The following substances, at the specified saturated solvent/diluent concentrations, do not interfere with the test results in the final concentrations listed:
Anthistamine (0.22 mg/ml), Ascorbic acid (1.0 mg/mL), Bilirubin (0.2 mg/mL), Boric acid (2.63 mg/mL) Ciprofloxacin (0.22 mg/ml), Cold and flu tablets (50 mg/ml), Cough drops (0.22 mg/ml), Cough syrup (0.20 mg/ml.), Decongestant (0.22 mg/ml.), Erythromycin (0.067 mg/mL), Glucose (20 mg/mL), Protein (BSA) (5 mg/mL), Rifampicin (0.09 mg/mL), Urea (20 mg/mL), White blood cells (10%), Whole blood (10%).
Cross-reactivity Study
Potentially cross-reactive microorganisms that might be present in urine samples from healthy persons or patients suspected of having L. pneumophila infection were added at a final concentration of 1.2 x 10° CFU/mL (bacteria or fungi) or a final concentration greater than 1 x 10 TCIDso/ml (viruses) to a pooled negative and a contrived positive sample. The negative specimen was prepared from a pool of donor urine that was confirmed negative. The contrived positive sample was prepared by spiking a confirmed negative sample with Legionella pneumophila Philadelphia strain antigen at 3.76 x 10' CFU/mL, the limit of detection for this assay. Dilution controls for each sample were prepared by adding a saline solution in place of the potentially cross-reactive organisms.
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| 510(k) Application TRU Legionella | ||
|---|---|---|
| Description: | 510(k) Summary | |
| Bioscience, Inc. | Identification: | Attachment 002 |
| Date: | October 28, 2011 |
The following microorganisms, at the indicated concentrations, do not interfere with TRU Legionella test results: Alcaligenes faecalis, Bacillus subtilis, Candida albicans, Candida glabrata, Candida parapsilosis, Citrobacter freundii, Enterobacter aerogenes, Enterococcus faecalis, Enterococcus faecium, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Legionella dumoffi, Legionella feeleii, Legionella gormanii, Legionella micdadei, Legionella pneumophila serogroup 2, Legionella pneumophila serogroup 3, Legionella pneumophila serogroup 4, Legionella pneumophila serogroup 5, Legionella pneumophila serograup 6, Morganella osloensis, Nocardia asteroides, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia Inquefaciens, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus groups A, B, D, F, G, Streptococcus pneumoniae, Adenovirus, Coxsackievirus, Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus A, Respiratory Syncytial Virus B.
Strain Reactivity
The following L. pneumophila stock cultures from different sources were tested and produced positive reactions at concentrations of 4.8 x 10° CFU/mL or lower with the TRU Legionella assay:
Pontiac subgroup: CCUG 13395; NCTC 12024, Allentown 1; NCTC 12006, Benidorm; CCUG 33058, Knoxville; NCTC 12007, France.
Non-Pontiac subgroup: NCTC 12008, OLDA; NCTC 12098, Camperdown; NCTC 12025, Heysham; NCTC 12009, Oxford.
Performance Comparison, Clinical Tests
Clinical trials for the TRU Legionella assay were conducted August - October 2011. Performance characteristics of the TRU Legionella assay were determined by comparison to the Binax NOW Legionella Urinary Antigen test. Independent clinical test sites located in the Southeastern regions of the United States and an independent test site in the Netherlands evaluated a total of 428 qualified patient samples. The US clinical trial sites evaluated both retrospective frozen samples and prospectively collected samples, the retrospective samples were samples that had been previously submitted for Legionella testing. The site located in the Netherlands evaluated 220 frozen samples, chosen from a well characterized repository of urine samples collected from patients with confirmed Legionnaires Disease as well as negative specimens from patients suspected of infection by Legionello. Samples were collected from 272 (63.6%) males and 134 (31.3%) females. The age groups of patients ranged from 6 years. Overall positive percent agreement was determined to be 96.3%; overall negative percent agreement was determined to be 100.0%. Subsequent tables show overall assay performance as well as performance by clinical site.
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Image /page/4/Picture/0 description: This image shows a table with information about a 510(k) application for TRU Leglonella. The table includes the description, identification, and date of the application. The description is "510(k) Summary", the identification is "Attachment 002", and the date is "October 28, 2011".
Table 3: Comparison of TRU Legionella to Binax NOW Legionella (Retrospective and Prospective Specimens)
| TRU Legionella | ||||
|---|---|---|---|---|
| Binax NOW | Positive | Negative | Total | |
| Positive | 131 | 5 | 136 | |
| Negative | 0 | 292 | 292 | |
| Total | 131 | 297 | 428 | |
| 95% CI | ||||
| Positive Agreement | 131/136 | 96.3% | 91.7 - 98.4% | |
| Negative Agreement | 292/292 | 100.0% | 98.7 - 100.0% | |
| Correlation | 423/428 | 98.8% | 97.3 - 99.5% |
Table 4: Performance Characteristics by Site (Retrospective and Prospective Specimens)
| Clinical TrialSite | TRULegionella/Binax NOW | PositiveAgreement(%) | 95% CI | TRULegionella/Binax NOW | NegativeAgreement(%) | 95% CI |
|---|---|---|---|---|---|---|
| Site 1 | 6/6 | 100.0% | 61.0 - 100.0% | 60/60 | 100.0% | 94.0 - 100.0% |
| Site 2 | 103/108 | 95.4% | 89.6 - 98.0% | 104/104 | 100.0% | 96.4 - 100.0% |
| Site 3 | 3/3 | 100.0% | 43.9 - 100.0% | 78/78 | 100.0% | 93.5 - 100.0% |
| Site 4 | 19/19 | 100.0% | 83.2 - 100.0% | 50/50 | 100.0% | 92.9 - 100.0% |
Reproducibility
Reproducibility panels were performance by three clinical laboratories using blind coded panels. Samples were randomly sorted within each panel to mask identities. Each panel consisted of 3 contrived moderately positive specimens, 3 contrived low positived samples containing Legionella-negative specimens at or near the assay cutoff, and 1 natural negative specimen. Panels were tested at three independent laboratories; each laboratory tested two panels twice each day over five days. The overall correlation for the TRU Legionella reproducibility study was 100% (98.7 - 100.0%). The correlation between expected and achieved results for the moderate positive, low positive and weak negative specimens was 100.0%). The correlation for the high negative specimen was 100.0% (95.9 – 100.0%). Tables 5-7 contain the reproducibility data for the three sites.
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Meridian
Toscience, Inc.
| 510(k) Application TRU Legionella100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| Description: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Summar------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| dentification:1 | Attachment 002------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Date: | And Concession of Concession of ChildrenOctober 28, 2011 |
Table 5: Site 1 Reproducibility Data, Lot 751930B002
| Sample ID | Sample Result | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Run 1(HBD-S)* | Run 2(DM)* | Run 1(HBD-S)* | Run 2(DM)* | Run 1(HBD-S)* | Run 2(DM)* | Run 1(HBD-S)* | Run 2(DM)* | Run 1(HBD-S)* | Run 2(DM)* | ||
| Positive Control | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Negative Control | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Moderate Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Moderate Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| High Negative 2 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| Negative 1 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | |
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
egend: Pos = Positive; Neg = Negati
Initials of person performing testin
Limits of person performing testing.
Interpretation of Results:
Positive Test Result: Pink-red band of any color intensity at the Control and Test line positions.
Negative Test Result: Pink-red band at the Control line position only.
Internetion of Results:
Prositie Test Beault file niersing at test internal prositions.
Negative Test Result Printed band and Test line position only.
Merce the pink-ed
Page 6 of 8
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| //L.loscience,।ﻬProperty of the program and |
|---|
| ------------------------------------------------------------- |
| 510(k) Application TRU Legionella | |
|---|---|
| Description: | 510(k) Summary |
| Identification: | Attachment 002 |
| Date: | October 28, 2011 |
able 6: Site 2 Reproducibility Data, Lot 751930B003
| Sample ID | Sample Result | Day 1Run 1(CM)* | Day 1Run 2(LR)* | Day 2Run 1(CM)* | Day 2Run 2(LR)* | Day 3Run 1(CM)* | Day 3Run 2(LR)* | Day 4Run 1(CM)* | Day 4Run 2(LR)* | Day 5Run 1(CM)* | Day 5Run 2(LR)* |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive Control | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Negative Control | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Moderate Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Moderate Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| High Negative 2 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| Negative 1 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | |
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
egend: Pos = Positive; Neg = Negative
Initials of person performing testing.
.: initials of person performing testing:
Interpretation of Results:
Positive Test Result: Pink-red band of any color intensity at the Control and Test line positions.
Negative Test Result: Pink-red band at the Control line position only.
neerpreation of Results:
Positive Test Result Printersity at te Cartrel and Test ine positions.
Negative Test Result Printed band and apparing at the Text line position afte
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Meridian
ioscience, Inc.
| 510(k) Application TRU Legionella | |
|---|---|
| Jescription: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Summar |
| dentification:------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Attachment 002------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Date: | October 28, 2011 |
Table 7: Site 3 Reproducibility Data, Lot 751930B00
| Sample ID | Sample Result | Day 1Run 1(BD)* | Day 1Run 2(JH)* | Day 2Run 1(BD)* | Day 2Run 2(JH)* | Day 3Run 1(BD)* | Day 3Run 2(JH)* | Day 4Run 1(BD)* | Day 4Run 2(JH)* | Day 5Run 1(BD)* | Day 5Run 2(JH)* |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive Control | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Negative Control | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Moderate Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Moderate Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Moderate Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 1 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| Low Positive 2 | Positive | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos |
| Low Positive 3 | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | Pos | |
| High Negative 1 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| High Negative 2 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| High Negative 3 | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | |
| Negative 1 | Negative | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg | Neg |
| Percent Correlation | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | |
| Correlation of cut off Specimens | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
egend: Pos = Positive; Neg = Negati
Initials of person performing testin
.:. Inter person performing testing.
Interpretation of Results:
Positive Test Result: Pink-red band of any color intensity at the Control and Test line positions.
Negative Test Result: Pink-red band at the Control line position only.
inestreation of Results:
Positive Test Result Phicality on the Control and Test line positions.
Negative Test Result Printed band and and appearing at the Test line position
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
10903 New Hampshire Avenue Silver Spring, MD 20993
Meridian Bioscience, Inc. c/o Ms. Susan Bogar Product Quality Assurance Manager 3471 River Hills Drive Cincinnati, OH 45244
FEB 2 4 2012
Re: K113190
Trade/Device Name: TRU Legionella assay Regulation Number: 21 CFR 866.3300 Regulation Name: Haemophilus spp. Serological Reagents Regulatory Class: Class II Product Code: MJH Dated: January 26, 2012 Received: January 27, 2012
Dear Ms. Bogar:
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, listing 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), Parts 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 or any I vith 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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Page 2 - Ms. Susan Bogar
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality byonials (<described in your Section 510(k) premarket will anow you to begin marketing your device of your device to a legally marketed nonication. The PDA imanie of substitication 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 II you desire specific advice for your correstic Device Evaluation and Safety at (301) 796-007), prease condect the regulation entitled, "Misbranding by reference to premarket 5430. Also, please note the regarations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (27 Of NY Carl 807) persons of 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 1 ou may other general mormation. On J 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,
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use Form
510(k) Number (if known): _ K 1 13 190
Device Name:
Indications for Use:
The TRU Legionella assay is an in vitro, rapid, lateral-flow immunoassay for the qualitative detection of Legionella preumontila serogroup 1 antigens in human urine specimens. It is designed to test specimens from patients with symptoms of pneumonia. Test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection. A negative result does not preclude infection with Legionella pneumophila serogroup 1. Test results are to be used in conjunction with information obtained from the patient's clinical evaluation and other diagnostic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie Le. Cooke
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113190
Page 1 of
§ 866.3300
Haemophilus spp. serological reagents.(a)
Identification. Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused byHaemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.