(231 days)
Not Found
No
The description focuses on standard immunoassay technology and data analysis based on relative light units (RLU) and index values, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of antibodies to Borrelia burgdorferi, which aids in the diagnosis of Lyme disease. It does not provide any treatment or therapy for the disease.
Yes
The device is intended for the qualitative presumptive detection of IgG and IgM antibodies to Borrelia burgdorferi, which are used to support a clinical diagnosis of Lyme disease.
No
The device description clearly outlines a hardware-based immunoassay system (LIAISON® Analyzer) that performs physical steps like incubations, washing, and measuring light signals from a chemiluminescence reaction. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative presumptive detection of IgG and IgM antibodies to VIsE (variable major protein-like sequence, expressed) protein antigen of Borrelia burgdorferi in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a disease state (Lyme disease).
- Device Description: The description details a "chemiluminescence immunoassay (CLIA)" method performed on an analyzer. This is a common technique used in laboratory settings to analyze biological samples.
- Performance Studies: The document describes clinical trials and reproducibility studies using human serum samples to evaluate the device's performance in detecting antibodies related to Lyme disease.
- Predicate Device: The mention of a "Predicate Device" (K003754; Immunetics® C6 B. burgdorferi (Lyme) ELISA ™ Kit) which is also an IVD, further supports that this device falls under the same regulatory category.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® Borrelia burgdorferi assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative presumptive detection of IgG and IgM antibodies to VIsE (variable major protein-like sequence, expressed) protein antigen of Borrelia burgdorferi in human serum. This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Borrelia burgdorferi should not be used to exclude Lyme disease.
The LIAISON® Borrelia burgdorferi Serum Controls contains two assayed quality control sera (negative and positive) that are used to monitor the performance of the LIAISON® Borrelia burgdorferi assay.
Product codes (comma separated list FDA assigned to the subject device)
LSR
Device Description
The method for the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi is an indirect chemiluminescence immunoassay (CLIA). All assay steps and incubations are performed by the LIAISON® Analyzer, with the exception of the initial magnetic particle resuspension.
Recombinant antigens specific for Borrelia (VIsE antigens) are used for coating the magnetic particles (solid phase). Two mouse monoclonal antibodies (anti-human IgG and anti-human IqM) are linked to an isoluminol derivative (isoluminol-antibody coniugate).
During the first incubation, anti-Borrelia burgdorferi antibodies present in calibrators, samples or controls bind to the solid phase magnetic particles. Unbound material is removed by a wash cycle and isoluminol-antibody conjugates are added. During the second incubation, the antibody conjugates react with anti-Borrelia burgdorferi IgG and IgM antibodies that are already bound to the solid phase. The second incubation is followed by a wash cycle to remove unbound conjugate. Subsequently, the start reagents are added and a flash chemiluminescence reaction is thus induced. The light signal and hence the amount of isoluminol-antibody coniuqate is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of Borrelia burgdorferi antibodies present in calibrators, controls or samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
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
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external US laboratories and at DiaSorin, Inc. Testing was performed on prospective and retrospective samples were tested by LIAISON® Borrella burgdorferi and the comparator assay Immunetics® C6 B. burgdorferi (Lyme) ELISA ™ kit at the trial sites per the manufacturer's instructions for use. The study consisted of the following samples types and results.
Lyme Disease Testing Patients: Prospective samples (n=1038).
Forty-five samples were positive or equivocal by LIAISON® Borrelia burgdorferi in the 1038 prospective sample study. These 45 samples were then tested following the two step method with a standardized Western Blot assay (MarDx Marblot Western Blot IgG and IgM assay).
Fifty-six samples were positive or equivocal by the Immunetics® C6 B. buradorferi (Lyme) ELISA™. These 56 samples were also tested following the two step method.
Apparently Healthy Adult Blood Donors: Prospective samples from areas where Lyme disease is Endemic (n= 300) and Non-Endemic (n = 300).
Characterized Lyme Disease Samples. Retrospective samples provided by the Centers for Disease Control and Prevention (n=60).
LYMErix™ Vaccine Recipients: Retrospective samples (n=11). (LYMErix® manufactured by GlaxoSmithKline Biologicals)
A CDC Lyme serum panel: (n = 42) The samples are categorized as Normals (no Lyme Disease n=5). The remaining 37 samples have a clinical diagnosis of Lyme Disease and are presented as Time from Onset of disease.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the LIAISON® Borrelia burgdorferi Assay for comparative clinical trials consisted of running selected samples to support the intended use.
COMPARATIVE CLINICAL TRIALS:
Lyme Disease Testing Patients: Prospective samples (n=1038).
Positive Percent Agreement: 70.0% (35/50), 95% Confidence Interval: 57.6 - 80.5%
Negative Percent Agreement: 99.1% (973/982), 95% Confidence Interval: 98.4 - 99.5%
Overall: 97.1% (1008/1038), 95% Confidence Interval: 96.1 - 97.9%
Western Blot results for LIAISON positive/equivocal samples: out of 45 samples, 22 were W. Blot positive (6 IgM+, 12 IgG+, 4 both IgM and IgG+).
Western Blot results for Immunetics® C6 B. buradorferi (Lyme) ELISA™ positive/equivocal samples: out of 56 samples, 23 were W. Blot positive (6 IgM+, 13 IgG+, 4 both IgM and IgG+).
Apparently Healthy Adult Blood Donors:
Endemic (n=300): 297 Negative, 1 Equivocal, 2 Positive (0.7% Positive Prevalence).
Non-Endemic (n=300): 299 Negative, 0 Equivocal, 1 Positive (0.3% Positive Prevalence).
Characterized Lyme Disease Samples (n=60):
Positive Percent Agreement: 93.2% (41/44), 95% Confidence Intervals: 83.3 – 98.1%
Negative Percent Agreement: 81.3% (13/16), 95% Confidence Intervals: 58.3 – 94.5%
Overall: 90.0% (54/60), 95% Confidence Intervals: 83.3 – 95.5%
LYMErix™ Vaccine Recipients (n=11):
LIAISON® Borrelia burgdorferi Assay: Pre vaccine Negative: 3/3 (100%), 95% CI=36.9-100%; Post vaccine Negative: 11/11 (100%), 95% CI=76.1-100%.
Immunetics® C6 Lyme ELISA: Pre vaccine Negative, Post vaccine Negative. (No specific numbers given for C6 ELISA, only categories).
A CDC Lyme serum panel (n=42):
Normals (n=5): 0 Pos, 0 Eqv, 5 Neg, 100% Agreement.
0-1 Month (n=6): 5 Pos, 0 Eqv, 1 Neg, 83.3% Agreement.
1-2 Months (n=8): 6 Pos, 0 Eqv, 2 Neg, 75.0% Agreement.
3-12 Months (n=15): 8 Pos, 0 Eqv, 7 Neg, 53.3% Agreement.
1 year (n=8): 8 Pos, 0 Eqv, 0 Neg, 100% Agreement.
Total (n=42): 27 Pos, 0 Eqv, 15 Neg, 73.0% Agreement.
REPRODUCIBILITY: Reproducibility studies were performed at 3 sites using a coded panel comprised of 6 prepared serum samples. The same coded panel was tested at all 3 sites following CLSI EP15-A2. Panel samples were tested in four replicates per run, in one run per day, during five operating days.
Index Reproducibility:
Sample NC (Serum, N=60): mean Index 0.06, Within run %CV 6.77, between run %CV 8.26, total (by site) %CV 10.93, between site %CV 15.64, overall %CV 17.28.
Sample PC (Serum, N=60): mean Index 1.95, Within run %CV 5.07, between run %CV 5.92, total (by site) %CV 7.37, between site %CV 5.14, overall %CV 8.68.
Sample BPP1 (Serum, N=60): mean Index 0.90, Within run %CV 5.38, between run %CV 9.49, total (by site) %CV 10.68, between site %CV 11.70, overall %CV 14.42.
Sample BPP2 (Serum, N=60): mean Index 1.01, Within run %CV 3.94, between run %CV 9.07, total (by site) %CV 9.24, between site %CV 6.19, overall %CV 11.31.
Sample BPP3 (Serum, N=60): mean Index 6.8, Within run %CV 3.96, between run %CV 6.34, total (by site) %CV 7.68, between site %CV 2.01, overall %CV 8.66.
Sample BPP4 (Serum, N=60): mean Index 1.84, Within run %CV 3.45, between run %CV 7.85, total (by site) %CV 8.06, between site %CV 4.21, overall %CV 10.19.
Sample BPP5 (Serum, N=60): mean Index 0.44, Within run %CV 6.10, between run %CV 12.19, total (by site) %CV 12.66, between site %CV 13.76, overall %CV 17.57.
Sample BPP6 (Serum, N=60): mean Index 0.13, Within run %CV 5.88, between run %CV 10.66, total (by site) %CV 11.67, between site %CV 8.04, overall %CV 13.81.
RLU Reproducibility:
Sample NC (Serum, N=60): mean RLU 1516, within run %CV 5.76, between run %CV 6.10, total (by site) %CV 8.17, between site %CV 5.78, overall %CV 9.74.
Sample PC (Serum, N=60): mean RLU 44293, within run %CV 3.96, between run %CV 4.58, total (by site) %CV 5.80, between site %CV 8.85, overall %CV 9.58.
Sample BPP1 (Serum, N=60): mean RLU 21243, within run %CV 4.90, between run %CV 7.37, total (by site) %CV 8.85, between site %CV 8.12, overall %CV 11.79.
Sample BPP2 (Serum, N=60): mean RLU 23720, within run %CV 3.52, between run %CV 7.78, total (by site) %CV 8.03, between site %CV 4.63, overall %CV 10.24.
Sample BPP3 (Serum, N=60): mean RLU 143757, within run %CV 3.88, between run %CV 6.06, total (by site) %CV 7.41, between site %CV 5.63, overall %CV 9.77.
Sample BPP4 (Serum, N=60): mean RLU 42016, within run %CV 3.27, between run %CV 6.79, total (by site) %CV 7.21, between site %CV 6.34, overall %CV 10.73.
Sample BPP5 (Serum, N=60): mean RLU 10769, within run %CV 5.73, between run %CV 10.23, total (by site) %CV 11.01, between site %CV 7.61, overall %CV 14.31.
Sample BPP6 (Serum, N=60): mean RLU 3320, within run %CV 5.82, between run %CV 8.08, total (by site) %CV 9.64, between site %CV 6.57, overall %CV 12.58.
Studies were tested internally at DiaSorin Inc. using the same coded panel following CLSI EP5-A2. Samples were tested in 2 replicates per run, on 2 different instruments 2 times per day for 20 days.
Internal Reproducibility (Index):
Neg QC-A (N=160): Mean Index 0.07, within run SD 0.00, %CV 4.12; between run SD 0.01, %CV 8.02; between instrument SD 0.00, %CV 1.91; overall SD 0.01, %CV 9.24.
Pos QC-A (N=160): Mean Index 2.11, within run SD 0.07, %CV 3.42; between run SD 0.17, %CV 8.08; between instrument SD 0.05, %CV 2.42; overall SD 0.19, %CV 8.85.
BPP1 (N=160): Mean Index 1.11, within run SD 0.03, %CV 3.12; between run SD 0.08, %CV 7.64; between instrument SD 0.02, %CV 1.63; overall SD 0.09, %CV 8.22.
BPP2 (N=160): Mean Index 1.36, within run SD 0.08, %CV 6.10; between run SD 0.12, %CV 9.18; between instrument SD 0.01, %CV 0.71; overall SD 0.19, %CV 14.03.
BPP3 (N=160): Mean Index 7.6, within run SD 0.36, %CV 4.65; between run SD 0.50, %CV 6.59; between instrument SD 0.16, %CV 2.14; overall SD 0.70, %CV 9.12.
BPP4 (N=160): Mean Index 2.22, within run SD 0.07, %CV 3.18; between run SD 0.17, %CV 7.48; between instrument SD 0.05, %CV 2.11; overall SD 0.18, %CV 8.06.
BPP5 (N=160): Mean Index 0.62, within run SD 0.02, %CV 3.67; between run SD 0.05, %CV 8.81; between instrument SD 0.02, %CV 3.16; overall SD 0.06, %CV 9.49.
BPP6 (N=160): Mean Index 0.18, within run SD 0.01, %CV 5.59; between run SD 0.01, %CV 8.24; between instrument SD 0.00, %CV 0.35; overall SD 0.03, %CV 14.20.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement, Negative Percent Agreement, Overall Percent Agreement, Positive Prevalence, % Agreement (for CDC Lyme serum panel and Lyme vaccine recipients).
Reproducibility metrics: mean index/RLU, Within run %CV, between run %CV, total (by site) %CV, between site %CV, overall %CV (for external reproducibility).
Reproducibility metrics: mean index, within run SD, within run %CV, between run SD, between run %CV, between instrument SD, between instrument %CV, overall SD, overall %CV (for internal reproducibility).
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.
Immunetics® C6 B. burgdorferi (Lyme) ELISA ™ Kit - (K003754)
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
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY 5.0
APR 1 2 2007
| SUBMITTED BY: | Carol A. DePouw
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5850
Fax (651) 351-5669
Email: carol.depouw@diasorin.com |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE: | |
| Trade Name: | DiaSorin LIAISON® Borrelia burgdorferi
DiaSorin LIAISON® Borrelia burgdorferi
Serum Controls |
| Common Names/Descriptions: | Borrelia burgdorferi IgG/IgM |
| Classification Names: | Reagent, Borrelia Serological Reagent |
| Product Code: | LSR |
| PREDICATE DEVICES: | Immunetics® C6 B. burgdorferi (Lyme)
ELISA ™ Kit - (K003754) |
DEVICE DESCRIPTION:
INTENDED USE: The LIAISON® Borrelia burgdorferi assay and the LIAISON® Borrelia burgdorferi Serum Controls, use chemiluminescent immunoassay (CLIA) technology for the qualitative presumptive detection of IgG and IgM antibodies to Borrelia burgdorferi in human serum. This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme Disease. Positive or equivocal results should be supplemented by testing with a standardized Western Blot procedure. Positive supplemental results provide evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme Disease. Negative results by LIAISON® Borrelia burgdorferi assay should not be used to exclude Lyme Disease.
KIT DESCRIPTION: The method for the qualitative determination of IgG and IgM antibodies to Borrelia burgdorferi is an indirect chemiluminescence immunoassay (CLIA). All assay steps and incubations are performed by the LIAISON® Analyzer, with the exception of the initial magnetic particle resuspension.
1
Recombinant antigens specific for Borrelia (VIsE antigens) are used for coating the magnetic particles (solid phase). Two mouse monoclonal antibodies (anti-human IgG and anti-human IqM) are linked to an isoluminol derivative (isoluminol-antibody coniugate).
During the first incubation, anti-Borrelia burgdorferi antibodies present in calibrators, samples or controls bind to the solid phase magnetic particles. Unbound material is removed by a wash cycle and isoluminol-antibody conjugates are added. During the second incubation, the antibody conjugates react with anti-Borrelia burgdorferi IgG and IgM antibodies that are already bound to the solid phase. The second incubation is followed by a wash cycle to remove unbound conjugate. Subsequently, the start reagents are added and a flash chemiluminescence reaction is thus induced. The light signal and hence the amount of isoluminol-antibody coniuqate is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of Borrelia burgdorferi antibodies present in calibrators, controls or samples.
PERFORMANCE DATA:
Performance testing of the LIAISON® Borrelia burgdorferi Assay for comparative clinical trials consisted of running selected samples to support the intended use.
COMPARATIVE CLINICAL TRIALS: The clinical trials were conducted at two external US laboratories and at DiaSorin, Inc. Testing was performed on prospective and retrospective samples were tested by LIAISON® Borrella burgdorferi and the comparator assay Immunetics® C6 B. burgdorferi (Lyme) ELISA ™ kit at the trial sites per the manufacturer's instructions for use. The study consisted of the following samples types and results.
Lyme Disease Testing Patients: Prospective samples (n=1038).
| Percent Agreement | 95% Confidence Interval | |
|---|---|---|
| Positive | 70.0% (35/50) | 57.6 - 80.5% |
| Negative | 99.1% (973/982) | 98.4 - 99.5% |
| Overall | 97.1% (1008/1038) | 96.1 - 97.9% |
Forty-five samples were positive or equivocal by LIAISON® Borrelia burgdorferi in the 1038 prospective sample study. These 45 samples were then tested following the two step method with a standardized Western Blot assay (MarDx Marblot Western Blot IgG and IgM assay). Twenty-two of the 45 total samples were W. Blot positive. Of the 22 samples that were Western Blot positive, 6 were IgM +, 12 were lgG +, and 4 were both IgM and IgG +.
Fifty-six samples were positive or equivocal by the Immunetics® C6 B. buradorferi (Lyme) ELISA™. These 56 samples were also tested following the two step method. Twenty-three of the 56 total samples were W. Blot positive. Of the 23
2
samples that were Western Blot positive 6 were IgM +, 13 were IgG +, and 4 were both IgM and IgG +. A summary of the results are in the following table.
| Assay | Result | n | Combined IgG and IgM W. Blot results | |
|---|---|---|---|---|
| + | - | |||
| LIAISON | + | 41 | 22 | 19 |
| LIAISON | ± | 4 | 0 | 4 |
| C6 | ||||
| ELISA | + | 50 | 23 | 27 |
| C6 | ||||
| ELISA | ± | 6 | 0 | 6 |
Apparently Healthy Adult Blood Donors: Prospective samples from areas where Lyme disease is Endemic (n= 300) and Non-Endemic (n = 300). Reactivity/Prevalence in the Normal population was determined from these samples types.
| Population | N | Negative | Equivocal | Positive | % Positive Prevalence |
|---|---|---|---|---|---|
| Endemic | 300 | 297 | 1 | 2 | 0.7% |
| Non-Endemic | 300 | 299 | 0 | 1 | 0.3% |
-
Characterized Lyme Disease Samples. Retrospective samples provided by the Centers for Disease Control and Prevention (n=60).
| Percent Agreement | 95% Confidence Intervals | |||
|---|---|---|---|---|
| Positive | 93.2% | (41/44) | 83.3 – 98.1% | |
| Negative | 81.3% | (13/16) | 58.3 – 94.5% | |
| Overall | 90.0% | (54/60) | 83.3 – 95.5% |
-
LYMErix™ Vaccine Recipients: Retrospective samples (n=11). (LYMErix® manufactured by GlaxoSmithKline Biologicals)
| Immunetics® C6 Lyme ELISA | ||
|---|---|---|
| Pre vaccine Negative | Post vaccine Negative | |
| LIAISON® | ||
| Borrelia burgdorferi | ||
| Assay | 3 /3 (100%) | |
| 95% CI = 36.9 - 100% | 11/ 11 (100%) | |
| 95% CI = 76.1 - 100% |
- A CDC Lyme serum panel: (n = 42) The samples are categorized as Normals (no Lyme Disease n=5). The remaining 37 samples have a clinical diagnosis of Lyme Disease and are presented as Time from Onset of disease.
3
| LIAISON® Borrelia burgdorferi | |||||
|---|---|---|---|---|---|
| Time after | |||||
| Onset | Total | Pos | Eqv | Neg | % |
| Agreement | |||||
| Normals | 5 | 0 | 0 | 5 | 100% |
| 0-1 Month | 6 | 5 | 0 | 1 | 83.3% |
| 1-2 Months | 8 | 6 | 0 | 2 | 75.0% |
| 3-12 Months | 15 | 8 | 0 | 7 | 53.3% |
| > 1 year | 8 | 8 | 0 | 0 | 100% |
| Total | 42 | 27 | 0 | 15 | 73.0% |
Conclusion:
The results demonstrate that the LIAISON® Borrelia burgdorferi assay can be used with the LIAISON® Analyzer for the qualitative presumptive detection of IgG and IgM antibodies to Borrelia burgdorferi in human serum.
REPRODUCIBILITY: Reproducibility studies were performed at 3 sites using a coded panel comprised of 6 prepared serum samples. The same coded panel was tested at all 3 sites following CLSI EP15-A2. Panel samples were tested in four replicates per run, in one run per day, during five operating days.
The results expressed for Index and RLU's are summarized in the tables below.
| sample | | N | mean
Index | Within
run
%CV | between
run
%CV | total
(by site)
%CV | between
site
%CV | overall
%CV |
|--------|--------|----|---------------|----------------------|-----------------------|---------------------------|------------------------|----------------|
| ID# | matrix | | | | | | | |
| NC | Serum | 60 | 0.06 | 6.77 | 8.26 | 10.93 | 15.64 | 17.28 |
| PC | Serum | 60 | 1.95 | 5.07 | 5.92 | 7.37 | 5.14 | 8.68 |
| BPP1 | Serum | 60 | 0.90 | 5.38 | 9.49 | 10.68 | 11.70 | 14.42 |
| BPP2 | Serum | 60 | 1.01 | 3.94 | 9.07 | 9.24 | 6.19 | 11.31 |
| BPP3 | Serum | 60 | 6.8 | 3.96 | 6.34 | 7.68 | 2.01 | 8.66 |
| BPP4 | Serum | 60 | 1.84 | 3.45 | 7.85 | 8.06 | 4.21 | 10.19 |
| BPP5 | Serum | 60 | 0.44 | 6.10 | 12.19 | 12.66 | 13.76 | 17.57 |
| BPP6 | Serum | 60 | 0.13 | 5.88 | 10.66 | 11.67 | 8.04 | 13.81 |
Index Reproducibility
4
| sample | within | between | total | between | overall | |||
|---|---|---|---|---|---|---|---|---|
| ID# | matrix | N | mean | |||||
| RLU | run | |||||||
| %CV | run | |||||||
| %CV | (by site) | |||||||
| %CV | site | |||||||
| %CV | %CV | |||||||
| NC | Serum | 60 | 1516 | 5.76 | 6.10 | 8.17 | 5.78 | 9.74 |
| PC | Serum | 60 | 44293 | 3.96 | 4.58 | 5.80 | 8.85 | 9.58 |
| BPP1 | Serum | 60 | 21243 | 4.90 | 7.37 | 8.85 | 8.12 | 11.79 |
| BPP2 | Serum | 60 | 23720 | 3.52 | 7.78 | 8.03 | 4.63 | 10.24 |
| BPP3 | Serum | 60 | 143757 | 3.88 | 6.06 | 7.41 | 5.63 | 9.77 |
| BPP4 | Serum | 60 | 42016 | 3.27 | 6.79 | 7.21 | 6.34 | 10.73 |
| BPP5 | Serum | 60 | 10769 | 5.73 | 10.23 | 11.01 | 7.61 | 14.31 |
| BPP6 | Serum | 60 | 3320 | 5.82 | 8.08 | 9.64 | 6.57 | 12.58 |
RLU Reproducibility
Studies were tested internally at DiaSorin Inc. using the same coded panel following CLSI EP5-A2. Samples were tested in 2 replicates per run, on 2 different instruments 2 times per day for 20 days. The results are in the following table.
| ID | N | Mean
Index | within
run
SD | within
run
%CV | between
run
SD | between
run
%CV | between
instrument
SD | between
instrument
%CV | overall
SD | overall
%CV |
|-------------|-----|---------------|---------------------|----------------------|----------------------|-----------------------|-----------------------------|------------------------------|---------------|----------------|
| Neg
QC-A | 160 | 0.07 | 0.00 | 4.12 | 0.01 | 8.02 | 0.00 | 1.91 | 0.01 | 9.24 |
| Pos
QC-A | 160 | 2.11 | 0.07 | 3.42 | 0.17 | 8.08 | 0.05 | 2.42 | 0.19 | 8.85 |
| BPP1 | 160 | 1.11 | 0.03 | 3.12 | 0.08 | 7.64 | 0.02 | 1.63 | 0.09 | 8.22 |
| BPP2 | 160 | 1.36 | 0.08 | 6.10 | 0.12 | 9.18 | 0.01 | 0.71 | 0.19 | 14.03 |
| BPP3 | 160 | 7.6 | 0.36 | 4.65 | 0.50 | 6.59 | 0.16 | 2.14 | 0.70 | 9.12 |
| BPP4 | 160 | 2.22 | 0.07 | 3.18 | 0.17 | 7.48 | 0.05 | 2.11 | 0.18 | 8.06 |
| BPP5 | 160 | 0.62 | 0.02 | 3.67 | 0.05 | 8.81 | 0.02 | 3.16 | 0.06 | 9.49 |
| BPP6 | 160 | 0.18 | 0.01 | 5.59 | 0.01 | 8.24 | 0.00 | 0.35 | 0.03 | 14.20 |
Conclusion:
The material submitted in this premarket notification supports a substantial equivalence claim. The labelling is sufficient and satisfies the requirements of 21CFR 809.10.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol DePouw Regulatory Affairs Specialist DiaSorin, Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285
APR 1 2 2007
K062473 Re:
Trade/Device Name: LIAISON® Borrelia burgdorferi LIAISON® Borrelia burgdorferi Serum Controls Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: February 2, 2007 Received: February 5, 2007
Dear Ms. DePouw:
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 either class II (Special Controls) or class III (PMA), 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Sally, axtym
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
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Indications for Use
LIAISON® Borrelia burgdorferi
510(k) Number (if known): K062473
Device Name:
Indications For Use:
The LIAISON® Borrelia burgdorferi assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative presumptive detection of IgG and IgM antibodies to VIsE (variable major protein-like sequence, expressed) protein antigen of Borrelia burgdorferi in human serum. This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme disease. Positive or equivocal results should be supplemented by testing with a standardized Western blot procedure. Positive supplemental results provide evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme disease. Negative results by LIAISON® Borrelia burgdorferi should not be used to exclude Lyme disease.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jayart
Division Sign-Off
Page 1 of 1
Office of In Vita Diagnostic Device Eveluction and Safety
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Section 4
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Indications for Use
510(k) Number (if known): K062473
Device Name:
LIAISON® Borrelia burgdorferi Serum Controls
Indications For Use:
The LIAISON® Borrelia burgdorferi Serum Controls contains two assayed quality control sera (negative and positive) that are used to monitor the performance of the LIAISON® Borrelia burgdorferi assay.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jauzaix
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
Section 4
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