(406 days)
The EUROIMMUN Anti-SLA/LP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLA/LP in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 1, in coniunction with other laboratory and clinical findings.
The EUROIMMUN Anti-SLA/LP ELISA (IgG) consists of a microwell ELISA plate coated with SLA/LP antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:
Acceptance Criteria and Device Performance Study for EUROIMMUN Anti-SLA/LP ELISA (IgG)
The EUROIMMUN Anti-SLA/LP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLA/LP in human serum and plasma, used as an aid in the diagnosis of autoimmune hepatitis, type 1, in conjunction with other laboratory and clinical findings.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance characteristic (e.g., "Sensitivity must be >X%"). Instead, it presents the results of various studies as proof of the device's performance, implying that these results are considered acceptable for market clearance. The comparison to a predicate device and the clinical study results form the basis of showing substantial equivalence.
Based on the provided information, the following table summarizes the key performance metrics and the reported results:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Precision/Reproducibility | |
| Intra-assay reproducibility (no positive sample found negative and vice versa). | Based on 20 determinations for 8 samples across different ratio ranges: - Samples with Mean Ratios 0.2 to 0.9 (Negative Expected): 0% positive, 100% negative. - Samples with Mean Ratios 1.1 to 4.9 (Positive Expected): 100% positive, 0% negative. Result: Sufficient, as no positive sample was found negative and vice versa. |
| Inter-assay reproducibility (no positive sample found negative and vice versa). | Based on 24 determinations over 6 different runs for 8 samples across different ratio ranges: - Samples with Mean Ratios 0.2 to 0.8 (Negative Expected): 0% positive, 100% negative. - Samples with Mean Ratios 1.2 to 5.4 (Positive Expected): 100% positive, 0% negative. Result: Sufficient, as no positive sample was found negative and vice versa. |
| Lot-to-Lot reproducibility (no positive sample found negative and vice versa). | Based on QC samples using different lots over the measurement range: - Positive Samples (Mean Ratios 5.6, 7.6, 9.7, 0.9, 3.1, 3.9): 100% positive, 0% negative. - Negative Samples (Mean Ratios 0.1): 0% positive, 100% negative. Result: Sufficient, as no positive sample was found negative and vice versa. |
| Analytical Specificity / Cross-reactivity | - Panel of 18 sera serologically positive for antibodies against LKM were tested. Result: All 18 sera were negative in the Anti-SLA/LP ELISA (IgG), indicating no cross-reactivity. |
| Interference | - Concentrations of up to 1000 mg/dL for hemoglobin, 2000 mg/dL for triglyceride, and 40 mg/dL for bilirubin were tested. Result: Individual recovery was within 90 - 119%. No significant interference observed. |
| Method Comparison with Predicate Device | |
| Negative Agreement with predicate device | Result: 96.9% (154/159), 95% C.I.: 92.8% - 99.0% |
| Positive Agreement with predicate device | Result: 100.0% (31/31), 95% C.I.: 88.8% - 100.0% |
| Overall Agreement with predicate device | Result: 97.4% (185/190), 95% C.I.: 94.0% - 99.1% |
| Matrix Comparison (Serum vs. Plasma) | The 95% C.I. of the slope contains 1.0 and the 95% C.I. of the intercept contains 0 for EDTA plasma, Heparin plasma, and Citrate plasma when compared to serum. - EDTA plasma: y = -0.02 + 1.00x (95% C.I. intercept: -0.14 to 0.18, 95% C.I. slope: 0.94 to 1.06) - Heparin plasma: y = 0.02 + 1.00x (95% C.I. intercept: -0.06 to 0.21, 95% C.I. slope: 0.94 to 1.03) - Citrate plasma: y = 0.04 + 0.99x (95% C.I. intercept: -0.18 to 0.16, 95% C.I. slope: 0.94 to 1.05) Result: This condition indicates equivalence of concentration between serum and corresponding plasma matrices. Coefficients of determination were >0.99 and %BIAS from serum was 88-120%. |
| Clinical Sensitivity for AIH Type 1 | Result: 27.7% (95% C.I.: 17.3 - 40.2%) |
| Clinical Specificity | - Excluding AIH/PBC overlap samples: Result: 100.0% (95% C.I.: 99.2 - 100.0%) (435/435 negative out of 435 control samples). - Including AIH/PBC overlap samples: Result: 99.3% (95% C.I.: 98.1 - 99.9%) (447/450 negative out of 450 control samples). |
| Expected values/Reference range for healthy blood donors | - 150 apparently healthy blood donors tested. - Cut-off ratio 1.0. Result: All 150 blood donors found negative (0 positives, 150 negatives). Highest value was Ratio 0.8, Mean value 0.1. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision/Reproducibility:
- Intra-assay: 20 determinations for each of 8 samples.
- Inter-assay: 24 determinations for each of 8 samples over 6 different runs.
- Lot-to-Lot: 6 determinations (3 lots x 2 runs) for 4 samples and 16 to 38 determinations (n lots x 1 run) for 5 samples.
- Provenance: Not specified, but likely internal lab samples/controls as part of device development and validation.
- Analytical Specificity (Cross-reactivity):
- 18 sera positive for antibodies against LKM.
- Provenance: Not specified.
- Interference:
- 5 different specimens at different anti-SLA/LP concentrations (ratio 0.4 - 10.0), spiked with interfering substances.
- Provenance: Not specified.
- Method Comparison with Predicate Device:
- Total samples: 190 samples (167 initial, plus 23 additional samples created by mixing positive samples to cover the lower range).
- 58 from AIH patients
- 66 from PBC patients
- 15 from patients with AIH/PBC overlap syndrome
- 28 from patients with viral hepatitis
- Demographics: 30 men and 137 women, age 1 to 87 years (average 50 years).
- Provenance: "A study was performed in cooperation with a university clinical hospital," indicating a retrospective cohort from a clinical setting. Country of origin not specified, but likely within the geographic region of the university clinical hospital.
- Total samples: 190 samples (167 initial, plus 23 additional samples created by mixing positive samples to cover the lower range).
- Matrix Comparison:
- 16 sample pairs (serum and corresponding plasma).
- Provenance: Not specified.
- Clinical Study:
- Total samples: 515 clinically characterized samples.
- 65 from AIH-1 patients
- 68 from AIH-2 patients
- 15 from patients with AIH/PBC overlap syndrome
- 367 from other control groups (including viral hepatitis, toxic liver damages, steatohepatitis, PBC, PSC, and other autoimmune diseases like MCTD, celiac disease, Diabetes Type I, Hashimoto, Grave's disease, ulcerative colitis).
- Provenance: "Performed in cooperation with several university, hospital and private laboratories," indicating a retrospective cohort drawn from multiple clinical sites. Country of origin not specified.
- Total samples: 515 clinically characterized samples.
- Expected Values/Reference Range (Healthy Donors):
- 150 apparently healthy blood donors (mixed age and sex).
- Provenance: Not specified, but likely a healthy donor pool (e.g., blood bank).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth for any of the test sets (e.g., for the clinical study patients).
- For the "Method Comparison with Predicate Device" and "Clinical Study," samples were "clinically characterized" or from specific patient groups (e.g., "AlH patients," "AlH-1 patients"). This implies that the diagnosis (ground truth) was established through standard clinical practice by treating physicians and potentially confirmed by specialists, but the specific number and qualifications of these "experts" in the context of the study are not provided.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth diagnoses or for interpreting the results during the studies. The clinical characterization of samples likely represents the consensus diagnosis from the participating clinical sites.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is an in vitro diagnostic (IVD) ELISA kit for qualitative detection of autoantibodies, not an imaging or decision support AI device that would typically involve human-in-the-loop performance studies or require effect size reporting for human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance)
Yes, the performance data presented (precision, analytical specificity, clinical sensitivity, specificity, method comparison) reflects the standalone (algorithm-only) performance of the ELISA kit. As an IVD kit, its output is a quantitative ratio which is then interpreted qualitatively (positive/negative) based on a predefined cut-off. There is no human-in-the-loop directly affecting the assay's output. Clinicians would then interpret these results in conjunction with other clinical findings.
7. The Type of Ground Truth Used
- For Analytical Studies (Precision, Specificity, Interference): The "ground truth" was based on predefined characteristics of the samples (e.g., known positive/negative samples, samples spiked with interferents, samples with known LKM antibodies).
- For Method Comparison with Predicate Device: The ground truth was the result obtained from the FDA-cleared Inova Quanta Lite SLA ELISA (the predicate device), alongside the clinical diagnoses of the patients from whom the samples were drawn.
- For Clinical Studies: The ground truth was based on clinical characterization and diagnosis of the patients (e.g., "Autoimmune hepatitis type 1 (AIH-1) patients", "AIH/PBC overlap syndrome", "Viral hepatitis"). This type of ground truth represents outcomes data and expert clinical judgment based on recognized diagnostic criteria for these conditions, rather than a single gold-standard pathological finding for every case.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI development. This device is an ELISA kit, which is a biochemical assay, not an AI/ML algorithm that undergoes a distinct training phase in the same manner. The development and optimization of the assay (e.g., antigen selection, reagent concentrations, incubation times) would be analogous to a "training" process, but this is done through biochemical and analytical validation, not with a distinct data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the AI/ML sense is not applicable here. The "ground truth" for the development of the assay would come from internal studies using known positive and negative samples, characterized by established clinical diagnoses or reference methods, to optimize the assay's performance characteristics (e.g., cut-off determination, reagent concentrations). The clinical study and predicate device comparison data then serve as the independent validation of the optimized assay.
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EUROIMMUN US INC.
ATTACHMENT 1
1 - 1 - 2012
PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY (as required by 21 CFR § 807.92)
- A. 510(k)Number: K112221
- B. Purpose for Submission: New device
- ું Measurand: Anti-SLA/LP autoantibodies
- D. Type of Test: Qualitative enzyme immunoassay
- E. Applicant: EUROIMMUN US INC.
- F. Proprietary and Established Names: EUROIMMUN Anti-SLA/LP ELISA (IgG)
- G. Regulatory Information:
-
- Requlation:
-
·
- 21 CFR 866.5660 Multiple autoantibodies immunological test system
-
- Classification: Class II
- Product code: 3.
- NIY 4. Panel:
- Immunology
H. Intended Use:
-
- Intended use(s):
The EUROIMMUN Anti-SLA/LP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLA/LP in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 1, in coniunction with other laboratory and clinical findings.
- Intended use(s):
-
- Indication(s) for use: Same as intended use.
-
- Special conditions for the use statement(s):
For prescription use only.
- Special instrument requirements: র্ব
Microwell plate reader capable of measuring OD at 450nm for dual wavelength readings.
l. Device Description:
The EUROIMMUN Anti-SLA/LP ELISA (IgG) consists of a microwell ELISA plate coated with SLA/LP antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
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J. Substantial Equivalence Information:
- Predicate device name (s): 1. Inova Quanta Lite SLA ELISA
-
- Predicate 510(k) number(s):. K021482
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Intended use | Detection of IgG antibodies to SLA/LP* as an aid indiagnosis of autoimmune hepatitis. | Detection of IgG antibodies to SLA* as an aid indiagnosis of autoimmune hepatitis. |
| Technology | ELISA | Same |
| Assay platform | 96-well microtiter plates | Same |
| Assay format | Qualitative | Same |
| Calibration | Relative | Same |
| Antigen | Recombinant SLA/LP* antigen | Recombinant SLA* antigen |
| Substrate | TMB | Same |
| Reagent preparation | All reagents, calibrator and controls are ready to use,except for the wash buffer. | Same |
| Procedure | Sample incubation with micro-well antigen coated plate,followed by a wash step, incubation with an anti-humanIgG enzyme conjugate; wash step, incubation withsubstrate; then the addition of a stop solution andreading at 450nm. | Same |
| Differences | ||
| Item | New Device | Predicate Device |
| Conjugate | Rabbit anti-human IgG labeled with horseradishperoxidase | Goat anti-human IgG labeled with horseradishperoxidase |
| Calibrators andcontrols | 1 calibrator2 controls: 1 positive, 1 negative | 3 controls: 1 high positive, 1 low positive, 1 negative |
| Wash buffer | 10x concentrate | 40x concentrate |
| Stop solution | 0.5 M sulphuric acid | 0.344 M sulphuric acid |
| Sample types anddilution | Serum or plasma1:101 dilution | Serum1:101 dilution |
| Reported results | Ratio | Units |
| Cut off level | Ratio 1.0 | 25 Units |
- Although named differently, the antigen used predicate device is not different. Wies et al. have found that the antigens soluble liver antigen (SLA) and liver-pancreas antigen (LP) are the same and suggested to use the combined name "SLA/LP". Inova does not follow this recommendation.
Wies I. Brunner S. Henninger J. et al. Identification of target antigen for SLA/LP autoantibodies in autoimmune hepalitis. Lancet 2000; 355: 1510-15.
K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
Patient samples are diluted 1:101 in sample buffer, 100 pl of each diluted patient sample and pre-diluted controls and calibrator are added to the antigen coated microtiter wells and incubated for 30 minutes at room temperature. After incubation the microtiter well strips are washed with wash buffer to remove unbound antibodies and 100 ul of the anti-human IgG enzyme conjugate reagent is added to each microtiter well. After an additional 30-minutes incubation at room temperature, the microiter wells are again washed 3 times with 300 µl of wash buffer to remove any unbound enzyme conjugate and 100 µi of the chromogen substrate is added. The strips are incubated for 15 minutes at room temperature and 100 µl stop solution is added. The microtiter plates are placed in an ELISA reader and read at a wavelength of 450 nm and a reference wavelength of between 620 nm and 650 nm within 30 minutes.
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M. Performance Characteristics (where applicable):
- Analytical performance: 1.
- a. Precision/Reproducibility:
The reproducibility of the test was investigated with samples at different points on the calibration curve. Intra-assay reproducibility is based on 20 determinations and inter-assay reproducibility on 24 determinations performed in 6 different runs (days) according to the package insert. Both intra-assay and inter-assay reproducibility were found to be sufficient as no positive sample was found negative and vice versa. The following results were obtained:
| Anti-SLA/LP ELISA (IgG) | ||||||||
|---|---|---|---|---|---|---|---|---|
| n = 20 | Ratio | |||||||
| Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | Sample 7 | Sample 8 | |
| Mean value (x): | 0.2 | 0.4 | 0.9 | 1.1 | 1.3 | 1.6 | 3.6 | 4.9 |
| Range of values: | 0.2 - 0.2 | 0.4 - 0.4 | 0.8 - 0.9 | 1.1 - 1.2 | 1.1 - 1.4 | 1.5 - 1.7 | 3.4 - 3.7 | 4.6 - 5.3 |
| Expected result: | neg | neg | neg | pos | pos | pos | pos | pos |
| % positive: | 0% | 0% | 0% | 100% | 100% | 100% | 100% | 100% |
| % negative: | 100% | 100% | 100% | 0% | 0% | 0% | 0% | 0% |
Intra-assav reproducibility
Inter-assay reproducibility
| n = 24 | Anti-SLA/LP ELISA (IgG)Ratio | |||||||
|---|---|---|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | Sample 7 | Sample 8 | |
| Mean value (x): | 0.2 | 0.4 | 0.8 | 1.2 | 1.2 | 1.7 | 3.9 | 5.4 |
| Range of values: | 0.2 - 0.3 | 0.3 - 0.4 | 0.8 - 0.9 | 1.0 - 1.3 | 1.0 - 1.3 | 1.6 - 1.8 | 3.4 - 4.2 | 4.7 - 5.8 |
| Expected result: | neg | neg | neg | pos | pos | pos | pos | pos |
| % positive: | 0% | 0% | 0% | 100% | 100% | 100% | 100% | 100% |
| % negative: | 100% | 100% | 100% | 0% | 0% | 0% | 0% | 0% |
The Lot to Lot reproducibility was investigated during the validaton and quality control of the kit using different lots with QC samples distributed over the measurement range. Lot to lot reproducibility was found to be sufficient as no positive sample was found negative and vice versa. The following results were obtained:
| Anti-SLA/LP ELISA (IgG)Ratio | |||||
|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 3 | Sample 4 | ||
| n | 6* | 6* | 6* | 6* | |
| Mean value (x): | 5.6 | 7.6 | 9.7 | 0.9 | |
| Range of values: | 5.4 - 6.0 | 7.3 - 8.0 | 9.5 - 9.9 | 0.9 - 0.9 | |
| Expected result: | pos | pos | pos | pos | |
| % positive: | 100% | 100% | 100% | 100% | |
| % negative: | 0% | 0% | 0% | 0% | |
| Anti-SLA/LP ELISA (IgG)Ratio | |||||
| Sample 5 | Sample 6 | Sample 7 | Sample 8 | Sample 9 | |
| n | 38** | 38** | 16** | 10** | 10** |
| Mean value (x): | 3.1 | 3.9 | 0.1 | 0.1 | 0.1 |
| Range of values: | 2.1 - 4.1 | 3.2 - 4.6 | 0.1 - 0.2 | 0.1 - 0.2 | 0.1 - 0.2 |
| Expected result: | pos | pos | neg | neg | neg |
| % positive: | 100% | 100% | 0% | 0% | 0% |
| % negative: | 0% | 0% | 100% | 100% | 100% |
Lot to lot reproducibility
*3 lots x 2 runs ** n lots x 1 run
Linearity/assay reportable range: b.
Not applicable.
- Traceability, Stability, Expected values (controls, calibrators or methods): C.
- There is no recognized standard or reference material for antibodies. Results are given as ratios.
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-
d. Limit of detection:
Not applicable. -
Analytical specificity: e.
Cross-reactivity: The quality of the antigen used and the antigen source a high specificity of the ELISA. Cross reactivity was investigated using a panel of 18 sera serologically positive for antibodies against LKM. All 18 sera were negative in the Anti-SLA/LP ELISA (lgG), so no cross reactivity is expected.
Interference: To investigate the influence from hemoglobin, triglycerides and bilirubin, 5 different specimens at different anti-SLA/LP concentrations (ratio 0.4 - 10.0) were spiked with potential interfering substances and were incubated with the test system. The recovery in relation to the unspiked sample without interferent was calculated. The individual recovery was within the range of 90 - 119%. No significant interference was observed for concentrations of up to 1000 mg/d for hemoglobin, 2000 mg/dl for triglyceride and 40 mg/dl for bilirubin.
- f. Assay cut-off:
Ratio 1.0
2. Comparison studies:
- a. Method comparison with predicate device:
A study was performed in cooperation with a university clinical hospital comparing the performance of the EUROIMMUN Anti- SLA/LP ELISA (IgG) and an FDA released predicate device. 167 samples were investigated (58 from AlH patients, 66 from PBC patients, 15 from patients with AIH/PBC overlap syndrome and 28 from patients with viral hepatitis). The panel consisted of 30 men and 137 women. Age ranged from 1 to 87 years with an average age of 50 years. To cover the lower range with more samples, additional 23 samples were created by mixing of positive samples. Borderline samples were considered for positive agreement.
| n = 190 | Predicate ELISA | |||
|---|---|---|---|---|
| positive | borderline | negative | ||
| EUROIMMUNAnti-SLA/LP ELISA (IgG) | positive | 30 | 1 | 5 |
| EUROIMMUNAnti-SLA/LP ELISA (IgG) | negative | 0 | 0 | 154 |
| Negative agreement | 154 / 159 = 96.9% | 95% C.I.: 92.8% - 99.0% | ||
| Positive agreement | 31 / 31 = 100.0% | 95% C.I.: 88.8% - 100.0% | ||
| Overall agreement | 185 / 190 = 97.4% | 95% C.I.: 94.0% - 99.1% |
Matrix comparison: b.
The usability of plasma was investigated using 16 sample pairs each of serum and corresponding plasma. The samples cover concentrations in the diagnostically important range and the cut-off. Passing-Bablok regression was calculated for the comparison of serum to plasma. The results are shown in the table below.
| EDTA plasma | Heparin plasma | Citrate plasma | |
|---|---|---|---|
| Regression equation(y = plasma, x = serum) | $y = -0.02 + 1.00 x$ | $y = 0.02 + 1.00 x$ | $y = 0.04 + 0.99 x$ |
| 95% C.I. of intercept | -0.14 to 0.18 | -0.06 to 0.21 | -0.18 to 0.16 |
| 95% C.I. of slope | 0.94 to 1.06 | 0.94 to 1.03 | 0.94 to 1.05 |
A comparison in which the 95% C.I. of the slope contains 1.0 and the 95% C.I. of the intercept contains 0 indicates equivalence of concentration between serum and the corresponding plasma matrices. The comparisons above satisfy this condition.
Coefficients of determination were found to be above 0.99 and %BIAS from serum was in the range of 88 to 120 % (serum = 100 %).
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3. Clinical studies:
In a clinical study, performed in cooperation with several university, hospital and private laboratories, in total 515 clinically characterized samples (65 from AlH-1 patients, 68 from AlH-2 patients, 15 from patiens with AIH/PBC overlap syndrome and 367 from other control groups) were investigated for anti-SLA/LP antibodies (IgG). The EUROIMMUN Anti-SLA/LP ELISA (IgG) showed a sensitivity for AIH type 1 of 27.7% (95% C.I.: 17.3 - 40.2%). The specificity was 100.0% (95% C.I.: 99.2 - 100.0%) without the AIH/PBC overlap samples; specificity was 99.3% (95% C.I.: 98.1 - 100%) when these samples were included.
- Clinical sensitivity: a.
| Panel | Acres of the compressAnti-SLA/LP ELISA (IgG) | ||||
|---|---|---|---|---|---|
| No. | positive | 0 | 95% C.I. | ||
| Autoimmune hepatitis type 1 (AIH-1) | 65 | 27.7% | 3 - 40.2%the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the f |
b. Clinical specificity:
| No. | Panel | n | Anti-SLA/LP ELISA (IgG) | ||
|---|---|---|---|---|---|
| negative | % | 95% C.I. | |||
| 2 | AIH/PBC overlap syndrome | 15 | 12 | 80.0% | 51.9 - 95.7% |
| 3 | Autoimmune hepatitis type 2 (AIH-2) | 68 | 68 | 100.0% | 91.0 - 100.0% |
| 4 | Viral hepatitis | 118 | 118 | 100.0% | 96.9 - 100.0% |
| 5 | Toxic liver damages | 14 | 14 | 100.0% | 76.8 - 100.0% |
| 6 | Steatohepatitis | 24 | 24 | 100.0% | 85.8 - 100.0% |
| 7 | Primary biliary liver cirrhosis (PBC) | 111 | 111 | 100.0% | 96.7 - 100.0% |
| 8 | Primary sclerosing cholangiitis (PSC) | 19 | 19 | 100.0% | 82.4 - 100.0% |
| 9 | Other autoimmune diseases* | 81 | 81 | 100.0% | 95.5 - 100.0% |
| Total (without panel 2) | 435 | 435 | 100.0% | 99.2 - 100.0% | |
| Total (including panel 2) | 450 | 447 | 99.3% | 98.1 - 99.9% |
*from the following groups: MCTD (n = 20), celiac disease (n = 11), Diabetes Type I (n = 12), Hashimoto (n = 11), Grave's C. . disease (n = 12), ulcerative colitis (n = 15)
- Other clinical supportive data (when a. and b. are not applicable): d. Not applicable.
4. Clinical cut-off:
See Assay cut-off.
- ട്. Expected values/Reference range:
The levels of anti-SLA/LP antibodies (IgG) were analyzed with the EUROIMMUN Anti-SLA/LP ELISA (IgG) in a panel of 150 apparently healthy blood donors (mixed age and sex). With a cut-off of ratio 1.0, all blood donors were found negative.
| Positives | 0 |
|---|---|
| Negatives | 150 |
| Lowest value | Ratio 0.0 |
| Highest value | Ratio 0.8 |
| Mean value | Ratio 0.1 |
| Std dev. (SD) | Ratio 0.11 |
| 95th percentile | 0.3 |
| 99th percentile | 0.6 |
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
். Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Date
Signature
Kathryn Kohl, Managing Director Typed Name, Title
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 1 1 2012
EUROIMMUN US, Inc. c/o Ms. Kathryn Kohl Managing Director 1100 The American Road Morris Plains, NJ 07950
Re: K112221
Trade/Device Name: EUROIMMUN Anti-SLA/LP (IgG) Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: II Product Code: NIY Dated: September 5, 2012 Received: September 7, 2012
Dear Ms. Kohl:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
Maria Chan, Ph.D. ্র দ Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112221
Device Name: Anti-SLA/LP ELISA (IgG)
Indications For Use:
The EUROIMMUN Anti-SLA/LP ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against SLA/LP (soluble liver antigen/liverpancreas antigen) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 1, in conjunction with other laboratory and clinical findings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
signature
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K11222
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).