(116 days)
Not Found
No
The device description and performance studies describe a standard lateral-flow immunoassay, with no mention of AI or ML components.
No
The device is an in vitro diagnostic assay used for qualitative detection of an antigen and aid in diagnosis of an infection, not for treatment.
Yes
The intended use explicitly states that the test results are to be used as an aid in diagnosis of Legionella pneumophila serogroup 1 infection.
No
The device description explicitly states it is an "in vitro, rapid, lateral-flow immunoassay" and lists physical components like "Test Strips," "Sample Diluent/Negative Control," and "Positive Control," indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the TRU Legionella assay is an in vitro assay for the detection of Legionella pneumophila serogroup 1 antigen in human urine specimens. It is designed to be used as an aid in the diagnosis of infection.
- Device Description: The "Device Description" also reiterates that it is an in vitro assay.
- Anatomical Site: It tests human urine specimens, which are biological samples taken from the body.
- Performance Studies: The description of the performance studies clearly indicates that the device was tested using patient samples (human urine specimens) to evaluate its performance in detecting the target antigen.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for 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.
Product codes
MJH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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 Legionella. Samples were collected from 272 (63.6%) males and 134 (31.3%) females. The age groups of patients ranged from 6 years.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Limit of Detection (LoD):
- Philadelphia strain (Pontiac subgroup; ATCC 33152): $3.76 \times 10^5$ CFU/mL
- Bellingham strain (non-Pontiac subgroup; NCTC 11404): $5.2 \times 10^5$ 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. 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.
Clinical Tests:
Overall positive percent agreement was determined to be 96.3%; overall negative percent agreement was determined to be 100.0%.
Comparison of TRU Legionella to Binax NOW Legionella (Retrospective and Prospective Specimens) (N=428):
Positive Agreement: 131/136 (96.3%, 95% CI: 91.7 - 98.4%)
Negative Agreement: 292/292 (100.0%, 95% CI: 98.7 - 100.0%)
Correlation: 423/428 (98.8%, 95% CI: 97.3 - 99.5%)
Performance Characteristics by Site (Retrospective and Prospective Specimens):
Site 1: Positive Agreement 100.0% (61.0 - 100.0%), Negative Agreement 100.0% (94.0 - 100.0%)
Site 2: Positive Agreement 95.4% (89.6 - 98.0%), Negative Agreement 100.0% (96.4 - 100.0%)
Site 3: Positive Agreement 100.0% (43.9 - 100.0%), Negative Agreement 100.0% (93.5 - 100.0%)
Site 4: Positive Agreement 100.0% (83.2 - 100.0%), Negative Agreement 100.0% (92.9 - 100.0%)
Reproducibility:
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%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement: 96.3%
Negative Agreement: 100.0%
Correlation: 98.8%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Drive |
| Cincinnati, Ohio 45244 | |
| Contact: | Susan Bogar |
| Contact number: | (513) 271-3700 |
| Device name: | TRU Legionella |
| Common name: | Device Legionella, Spp., Elisa |
| Classification: | Haemophilus spp serological reagents |
| MJH, 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.
1
Image /page/1/Picture/0 description: The image shows the logo for Meridian Bioscience, Inc. The logo consists of a globe graphic on the left, followed by the word "Meridian" in a large, bold font. Below "Meridian" is the text "Bioscience, Inc." in a smaller, bold font. There is a line separating the word "Meridian" and the text "Bioscience, Inc."
| 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 membrane |
| assay | ||
| 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 Strip | |
| Conjugate Tube | ||
| Sample Diluent/Negative Control | ||
| Positive Control | ||
| Plastic transfer pipettes with 100, 200 and | ||
| 300 µL volume marks | Test Device | |
| Reagent A | ||
| Positive Control Swab | ||
| Negative Control Swab | ||
| Swabs | ||
| 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 to | |
| Conjugate Tube. Vortex for 10 seconds. |
- Add 100 µl of thoroughly mixed urine
sample to the Conjugate Tube. - Mix sample and conjugate thoroughly. | 1. Dip swab into the urine sample and then
insert swab into the bottom hole of the Test
Device. - Add 2 drops of Reagent A to the bottom
hole. |
| Testing Time | Approximately 20 minutes | Approximately 15 minutes |
| Equipment | | |
| General Laboratory Equipment | Vortex
Interval timer
Disposable latex gloves | Timer
Urine collection container
BinaxNOW® Legionella Urinary Antigen
Control Swab Pack |
| Reading Method | Visual | Visual |
| Results Interpretation | | |
| Visual Read | Negative: A PINK-RED band at the Control
Line position. No other bands are present.
Positive: PINK-RED band of any color
intensity at the Control and Legionella Test
Line positions.
Invalid: No band at the Control Line
position, a pink-red band appearing after
21 minutes of incubation, or a band of any
other color than pink-red. | Negative: Single pink to purple colored
Control line visible in the top half of the
window.
Positive: Two pink to purple colored lines.
Invalid: No line at the Control Line position
or no lines at the Control or Sample Line
positions. |
2
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.
3
| 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.
4
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 Trial
Site | TRU
Legionella
/Binax NOW | Positive
Agreement
(%) | 95% CI | TRU
Legionella
/Binax NOW | Negative
Agreement
(%) | 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.
5
Meridian
Toscience, Inc.
| 510(k) Application TRU Legionella
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|---|---|
| Description: | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| 510(k) Summar | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| dentification: | |
| 1 | Attachment 002 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
| Date: | And Concession of Concession of Children |
| October 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
6
| //L.
loscience,
।
ﻬ
| Property 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 1
Run 1
(CM)* | Day 1
Run 2
(LR)* | Day 2
Run 1
(CM)* | Day 2
Run 2
(LR)* | Day 3
Run 1
(CM)* | Day 3
Run 2
(LR)* | Day 4
Run 1
(CM)* | Day 4
Run 2
(LR)* | Day 5
Run 1
(CM)* | Day 5
Run 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
7
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 1
Run 1
(BD)* | Day 1
Run 2
(JH)* | Day 2
Run 1
(BD)* | Day 2
Run 2
(JH)* | Day 3
Run 1
(BD)* | Day 3
Run 2
(JH)* | Day 4
Run 1
(BD)* | Day 4
Run 2
(JH)* | Day 5
Run 1
(BD)* | Day 5
Run 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
8
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
9
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 (