(91 days)
DiaSorin LIAISON® Control Toxo IgG II (K132234)
No
The description details a standard chemiluminescent immunoassay (CLIA) and its performance on an automated analyzer. There is no mention of AI, ML, or any algorithms beyond basic signal processing for RLU measurement and qualitative determination based on thresholds.
No.
This device is an in vitro diagnostic (IVD) device used to detect antibodies for diagnosis, not to treat a condition.
Yes
The Intended Use / Indications for Use section explicitly states that the device is "an aid in the diagnosis of Helicobacter pylori infection." Additionally, the output of the device is the "qualitative determination of IgG antibodies to Helicobacter pylori," which is used to diagnose the infection.
No
The device description clearly outlines a chemiluminescent immunoassay (CLIA) that involves physical components like magnetic particles, conjugates, and reagents, and is performed on a specific hardware analyzer (LIAISON® XL Analyzer). This is not a software-only device.
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 assay is for the "qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine a human specimen (serum) to provide information for diagnostic purposes.
- Device Description: The description details a "two-step, indirect chemiluminescence immunoassay (CLIA)" performed on a human sample (serum). This is a standard method for in vitro diagnostic testing.
- Performance Studies: The document describes clinical studies comparing the device to an FDA-cleared predicate device, which is a requirement for demonstrating the performance of an IVD. The metrics reported (Negative Percent Agreement, Positive Percent Agreement) are also typical for evaluating the performance of diagnostic tests.
- Controls: The mention of the "LIAISON® H. pylori IgG Control Set" being used to "monitor the performance of the LIAISON® H. pylori IgG assay" further confirms its use as a diagnostic test requiring quality control.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.
The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.
Product codes
LYR, JJX, JJQ
Device Description
The method for qualitative determination of IgG antibodies to Helicobacter pylori (H.pv/ori IgG) is a two-step, indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Helicobacter pylori antigen and a conjugate of anti-human IgG monoclonal antibodies to linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, H. pylori antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjugate reacts with H. pylori lgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of H. pylori IgG in calibrators, samples or controls. All assay steps and incubations are performed by the LIAISON® XL Analyzer.
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
Adults
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
A prospective study was performed to compare the performance of the LIAISON® H. pylori IgG assay to an FDA-cleared predicate device. The prospective study consisted of 504 samples collected from non-selected adult subjects sent to the laboratory for H. pylori IqG serological testing. The prospective population consisted of 504 adult subjects and collected from multiple locations geographical locations in the U.S. The samples were from 151 males (30%) and 353 females (70%), and collected from multiple U.S. geographical locations. Known ages ranged from 18 to 91 years. The observed prevalence of the LIAISON® H. pylori IgG assay was calculated from these 504 samples.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Clinical Studies:
A prospective study was performed with 504 samples to compare the performance of the LIAISON® H. pylori IgG assay to an FDA-cleared predicate device (Comparator Assay). Results summarized as negative and positive percent agreement with 95% confidence intervals.
LIAISON® H. pylori IgG vs. Comparator Assay
- Negative: 378/381, 99.2% (95% CI: 97.9 – 99.8%)
- Positive: 105/110, 95.5% (95% CI: 90.4 – 98.4%)
Prevalence:
The observed prevalence of the LIAISON® H. pylori IgG was 22.4% from the 504 samples.
Precision/Reproducibility:
-
12 Day Study: A within-laboratory precision study was performed consulting CLSI document EP5-A3. Six contrived serum samples (high negative, low positive, moderate positive H. pylori IgG) and kit controls (negative and positive) were assayed in duplicate, in two runs per day over 12 operating days with multiple technicians.
- Neg Ctrl Mean Index: 1341*, Total SD: 190, Total %CV: 14.2%
- Neg Ctrl Mean Index: 1320*, Total SD: 177, Total %CV: 13.4%
- Pos Ctrl Mean Index: 2.77, Total SD: 0.218, Total %CV: 7.9%
- Pos Ctrl Mean Index: 2.73, Total SD: 0.234, Total %CV: 8.6%
- Sample #1 Mean Index: 0.74, Total SD: 0.082, Total %CV: 11.1%
- Sample #2 Mean Index: 0.71, Total SD: 0.055, Total %CV: 7.7%
- Sample #3 Mean Index: 1.32, Total SD: 0.111, Total %CV: 8.4%
- Sample #4 Mean Index: 1.25, Total SD: 0.098, Total %CV: 7.9%
- Sample #5 Mean Index: 1.52, Total SD: 0.106, Total %CV: 7.0%
- Sample #6 Mean Index: 1.50, Total SD: 0.133, Total %CV: 8.9%
(*Precision calculations are based on signal (RLU) for the two negative controls)
-
5 Day Study: A reproducibility/precision study was performed at two external sites and internally at DiaSorin Inc. consulting CLSI document EP15-A3. Six contrived serum samples (high negative, low positive, moderate positive H. pylori IgG) and kit controls (negative and positive) were assayed in replicates of three, in two runs per day over 5 operating days with two technicians at each site.
- Neg Ctrl Mean Index: 1013*, Total SD: 80.4, Total %CV: 7.9%
- Neg Ctrl Mean Index: 996*, Total SD: 94.5, Total %CV: 9.5%
- Pos Ctrl Mean Index: 3.34, Total SD: 0.141, Total %CV: 4.2%
- Pos Ctrl Mean Index: 3.36, Total SD: 0.126, Total %CV: 3.7%
- Sample #1 Mean Index: 0.626, Total SD: 0.073, Total %CV: 11.7%
- Sample #2 Mean Index: 0.628, Total SD: 0.056, Total %CV: 9.0%
- Sample #3 Mean Index: 1.28, Total SD: 0.083, Total %CV: 6.5%
- Sample #4 Mean Index: 1.27, Total SD: 0.076, Total %CV: 6.0%
- Sample #5 Mean Index: 1.82, Total SD: 0.113, Total %CV: 6.2%
- Sample #6 Mean Index: 1.74, Total SD: 0.104, Total %CV: 6.0%
(*Precision calculations are based on signal (RLU) for the two negative controls)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Negative Percent Agreement: 99.2%
Positive Percent Agreement: 95.5%
Predicate Device(s)
IMMULITE® 2000 H. pylori IgG K000463
Reference Device(s)
DiaSorin LIAISON® Control Toxo IgG II (K132234)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, one behind the other. The faces are connected and appear to be flowing or merging together.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
DIASORIN, INC. KELLY R. SAUER REGULATORY AFFAIRS SPECIALIST 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285
Re:K161139
Trade/Device Name: Liaison H. pylori IgG, Liaison H. pylori IgG Control Set Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter fetus serological reagents Regulatory Class: I Product Code: LYR, JJX, JJQ Dated: April 15, 2016 Received: April 22, 2016
Dear Ms. Sauer:
This letter corrects our substantially equivalent letter of July 22, 2016.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Ribhi Shawar -S
For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161139
Device Name LIAISON® H. pylori IgG LIAISON® H.pylori IgG Control Set
Indications for Use (Describe)
The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.
The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
5.0 510(k) SUMMARY
| SUBMITTED BY: | Kelly R. Sauer
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5884
Fax (651) 351-5669
Email: kelly.sauer@diasorin.com |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | April 15, 2016 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® H. pylori IgG
LIAISON® H. pylori IgG Control Set |
| Common Names/Descriptions: | Helicobacter pylori IgG assay and
Helicobacter pylori IgG controls |
| Classification Names: | Campylobacter fetus serological reagents:
Class I, 21 CFR: 866.3110; Microbiology (83) |
| Product Code: | LYR - Campylobacter fetus serological reagents
JJX - Single (Specified) analyte controls
(assayed and unassayed)
JJQ - Colorimeter, photometer,
spectrophotometer for clinical use |
| PREDICATE DEVICES : | IMMULITE® 2000 H. pylori IgG
Reference K000463 (assay)
DiaSorin LIAISON® Control Toxo IgG II
(K132234) |
DEVICE DESCRIPTION:
INTENDED USE:
The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.
4
The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.
KIT DESCRIPTION:
The method for qualitative determination of IgG antibodies to Helicobacter pylori (H.pv/ori IgG) is a two-step, indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Helicobacter pylori antigen and a conjugate of anti-human IgG monoclonal antibodies to linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, H. pylori antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjugate reacts with H. pylori lgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of H. pylori IgG in calibrators, samples or controls.
All assay steps and incubations are performed by the LIAISON® XL Analyzer.
COMPARISON TO PREDICATE DEVICE:
The DiaSorin LIAISON H. pylori IgG assay is substantially equivalent in principle and performance to Siemens IMMULITE 2000 H. pylori IgG Assay (K000463) which was FDA cleared June 1, 2000.
| Table 1: Table of Similarities | ||
|---|---|---|
| Item | Device | |
| K161139 | Predicate | |
| K000463 | ||
| Intended Use | The LIAISON® H. pylori IgG assay | |
| uses chemiluminescent immunoassay | ||
| (CLIA) technology for the qualitative | ||
| determination of IgG antibodies to | ||
| Helicobacter pylori in human serum | ||
| from symptomatic adults as an aid in the | ||
| diagnosis of Helicobacter pylori | ||
| infection. Assay results should be used | ||
| in conjunction with other clinical or | ||
| laboratory data to assist the clinician in | ||
| making individual patient management | ||
| decisions. The test has to be performed | ||
| on the LIAISON® XL Analyzer. |
The LIAISON® H. pylori IgG Control
Set is intended for use as assayed
quality control samples to monitor the
performance of the LIAISON® H.
pylori IgG assay. | For in vitro diagnostic use with
the IMMULITE® 2000 Systems
Analyzers – for the qualitative
detection of IgG antibodies to
Helicobacter pylori in human
serum from symptomatic adults,
as an aid in the diagnosis of
Helicobacter pylori infection |
| Measured Analyte | IgG antibodies to H. pylori | Same |
5
| Table 1: Table of Similarities | |||
|---|---|---|---|
| Item | Device | ||
| K161139 | Predicate | ||
| K000463 | |||
| Assay Type | Solid Phase Two Step | ||
| Chemiluminescent | Same | ||
| Sample Handling | Automated | Same | |
| Reagent Storage | On-board or in refrigerator (@ 2-8°C | In refrigerator @, 2-8°C | |
| Calibration | Two point verification of stored master | ||
| curve | Same | ||
| Calibration | Qualitative assay | Same | |
| Calculation of Result | |||
| Sample Matrix | Human Serum | Same | |
| Sample SizeVolume | 10 uL | Same | |
| Controls | Provided separately | Same |
| Table 2 : Table of Differences | ||
|---|---|---|
| Item | Device | |
| K161139 | Predicate | |
| K000463 | ||
| Unit of Measure | Index | U/mL |
| Assay Time | 30 minutes | 60 minutes |
| Conjugate | Mouse monoclonal antibodies to | |
| human IgG linked to an isoluminol | ||
| derivative | Monoclonal murine anti-human | |
| IgG antibodies labeled with | ||
| alkaline phosphatase in buffer | ||
| Measurement System | Photomultiplier (flash | |
| chemiluminescence reader) | Luminometer | |
| Cutoff | 0.85 Index | 1.00 U/mL |
| Equivocal Zone | $0.80 - H. pylori IgG | Comparator Assay |
| ---------------------------------- | ------------------ | ----------- |
| Positive | Equivocal | |
| Positive | 105 | 7 |
| Equivocal | 1 | 2 |
| Negative | 4 | 4 |
| Total | 110 | 13 |
Table 3: H. pylori IgG Prospective Population Comparison
| Percent Agreement | 95% Confidence Interval | ||
|---|---|---|---|
| Negative | 378/381 | 99.2% | 97.9 – 99.8% |
| Positive | 105/110 | 95.5% | 90.4 – 98.4% |
D. Prevalence:
The observed prevalence of the LIAISON® H. pylori IgG assay was calculated from the 504 samples collected from adult subjects sent to the lab for H. pylori lgG testing. The samples were from 151 males (30%) and 353 females (70%), and collected from multiple U.S. geographical locations. Known ages ranged from 18 to 91 years.
The observed prevalence of the LIAISON® H. pylori IgG is 22.4%. However, the prevalence may vary depending upon geographical location, age, gender, type of test employed, specimen collection and handling procedures as well as clinical history of the patient.
PRECISION/REPRODUCIBILITY:
12 Day Study
A within-laboratory precision study was performed consulting CLSI document EP5-A3 in the preparation of the testing protocol. Six contrived serum samples containing high negative, low positive and moderate positive concentrations of H. pylori IgG and kit controls (negative and positive) as duplicate samples were assaved in duplicate, in two runs per day over 12 operating days with multiple technicians. The following withinlaboratory precision results (Table 4) were obtained from samples tested internally at DiaSorin Inc. in one kit lot using one LIAISON® XL Analyzer.
7
| Sample
ID | Mean
Index | Within Run | | Within Day | | Between Day | | Total | |
|--------------|---------------|------------|------|------------|------|-------------|-------|-------|-------|
| | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg Ctrl | 1341* | 115 | 8.6% | 46.8 | 3.5% | 145 | 10.8% | 190 | 14.2% |
| Neg Ctrl | 1320* | 120 | 9.1% | 52.6 | 4.0% | 119 | 9.0% | 177 | 13.4% |
| Pos Ctrl | 2.77 | 0.145 | 5.2% | 0.119 | 4.3% | 0.112 | 4.1% | 0.218 | 7.9% |
| Pos Ctrl | 2.73 | 0.144 | 5.3% | 0.176 | 6.5% | 0.053 | 1.9% | 0.234 | 8.6% |
| Sample
#1 | 0.74 | 0.049 | 6.6% | 0.043 | 5.7% | 0.051 | 6.8% | 0.082 | 11.1% |
| Sample
#2 | 0.71 | 0.048 | 6.7% | 0.000 | 0.0% | 0.030 | 4.2% | 0.055 | 7.7% |
| Sample
#3 | 1.32 | 0.071 | 5.4% | 0.040 | 3.1% | 0.075 | 5.7% | 0.111 | 8.4% |
| Sample
#4 | 1.25 | 0.081 | 6.5% | 0.015 | 1.2% | 0.053 | 4.3% | 0.098 | 7.9% |
| Sample
#5 | 1.52 | 0.076 | 5.0% | 0.074 | 4.9% | 0.000 | 0.0% | 0.106 | 7.0% |
| Sample
#6 | 1.50 | 0.084 | 5.6% | 0.042 | 2.8% | 0.095 | 6.3% | 0.133 | 8.9% |
Table 4. Within-Laboratory Precision
Sample N=48
*Precision calculations are based on signal (RLU) for the two negative controls
5 Day Study
A reproducibility/precision study was performed at two external sites and internally at DiaSorin Inc. consulting CLSI document EP15-A3 in the preparation of the testing protocol. Six contrived serum samples containing high negative, low positive and moderate positive concentrations of H. pylori IgG and kit controls (negative and positive) as duplicate samples were assayed in replicates of three, in two runs per day over 5 operating days with two technicians at each site performing the test every day. The following reproducibility/precision results (Table 5) were obtained from samples tested at the three sites in one kit lot.
8
| Sample | | Within Run | | Run to Run
Within Day | | Day to Day
Within Site | | Site to Site | | Total | |
|--------------|---------------|------------|------|--------------------------|------|---------------------------|------|--------------|------|-------|-------|
| ID | Mean
Index | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Neg Ctrl | 1013* | 54.0 | 5.3% | 25.4 | 2.5% | 19.1 | 1.9% | 50.4 | 5.0% | 80.4 | 7.9% |
| Neg Ctrl | 996* | 43.7 | 4.4% | 25.4 | 2.6% | 0.900 | 0.1% | 79.8 | 8.0% | 94.5 | 9.5% |
| Pos Ctrl | 3.34 | 0.111 | 3.3% | 0.060 | 1.8% | 0.013 | 0.4% | 0.062 | 1.9% | 0.141 | 4.2% |
| Pos Ctrl | 3.36 | 0.103 | 3.1% | 0.012 | 0.4% | 0.068 | 2.0% | 0.019 | 0.6% | 0.126 | 3.7% |
| Sample
#1 | 0.626 | 0.035 | 5.6% | 0.010 | 1.6% | 0.016 | 2.5% | 0.061 | 9.8% | 0.073 | 11.7% |
| Sample
#2 | 0.628 | 0.025 | 4.0% | 0.018 | 2.9% | 0.005 | 0.7% | 0.047 | 7.4% | 0.056 | 9.0% |
| Sample
#3 | 1.28 | 0.043 | 3.4% | 0.004 | 0.3% | 0.030 | 2.4% | 0.064 | 5.0% | 0.083 | 6.5% |
| Sample
#4 | 1.27 | 0.050 | 3.9% | 0.011 | 0.9% | 0.035 | 2.7% | 0.044 | 3.5% | 0.076 | 6.0% |
| Sample
#5 | 1.82 | 0.061 | 3.3% | 0.049 | 2.7% | 0.045 | 2.5% | 0.067 | 3.7% | 0.113 | 6.2% |
| Sample
#6 | 1.74 | 0.060 | 3.4% | 0.034 | 1.9% | 0.041 | 2.4% | 0.067 | 3.8% | 0.104 | 6.0% |
Table 5. Reproducibility
Sample N=90
*Precision calculations are based on signal (RLU) for the two negative controls
CONCLUSION:
The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labeling is sufficient and it satisfies the requirements of 21CFR 809.10.