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510(k) Data Aggregation
(106 days)
IBL-HAMBURG GMBH
The IBL Cortisol enzym linked immunosorbent assay is for the in-vitro-diagnostic quantitative determination of cortisol in human serum and saliva.
The Cortisol ELISA kit is useful as an aid in the differential diagnosis of Cushing syndrome and Addison's disease.
Solid phase enzyme-linked immunosorbent assay (ELISA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After the substrate reaction the intensity of the developed color is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
Here's an analysis of the acceptance criteria and the study proving device performance for the IBL Cortisol ELISA, based on the provided text:
Acceptance Criteria and Device Performance for IBL Cortisol ELISA
1. Table of Acceptance Criteria and Reported Device Performance
The submission document for K062626 does not explicitly state pre-defined acceptance criteria in a dedicated section. However, the performance data presented implicitly serves as the criteria the device met for clearance. Based on the "Device Performance" section, the following can be inferred as the de-facto acceptance measurements:
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Shelf Life (Complete Kit) | At least 9 months at 2-8 °C (based on predicate) | 9 months at 2-8 °C |
| Method Comparison (vs. IBL-Luminescence IA) | High correlation (r value close to 1) and acceptable linear regression for both serum and saliva samples. | Saliva: IBL-ELISA = 0.92 x IBL-Luminescence IA + 0.06 µg/dL; r = 0.995 (n = 130) |
| Serum: IBL-ELISA = 1.17 x IBL-Luminescence IA - 2.2 µg/dL; r = 0.997 (n = 129) | ||
| Method Comparison (vs. GC/MS) | High correlation (r value close to 1) and acceptable linear regression for serum samples. | Serum: IBL-ELISA = 0.97 x GCMS + 2.3 µg/dL; r = 0.982 (n = 33) |
| Interference | Minimal effect (+/- 20% of expected) on test results at specified concentrations. | Hemoglobin (4.0 mg/mL): 0.06; 0.33; 0.62 µg/dL (Cortisol) |
| Bilirubin (0.5 mg/mL): 0.07; 0.35; 0.63 µg/dL (Cortisol) | ||
| Triglyceride (30 mg/mL): 0.07; 0.40; 0.75 µg/dL (Cortisol) | ||
| Thimerosal (0.50 %): 0.19; 0.25; 0.34 µg/dL (Cortisol) | ||
| Blood (0.125 %): 0.09; 0.26 µg/dL (Cortisol) | ||
| NaN3 (0.60 %): 0.23; 0.31 µg/dL (Cortisol) (All met the |
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(198 days)
IBL-HAMBURG GMBH
The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitrodiagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma.
The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
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The provided document is a 510(k) premarket notification letter from the FDA to IBL-Hamburg GmbH regarding their IBL ARAb RRA Test Kit. This document formally approves the marketing of the device, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer the prompt.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC study details based only on the provided text.
The document primarily focuses on the regulatory aspects of the FDA's decision, such as:
- Device Name: IBL ARAb RRA Test Kit
- Regulation Number: 21 CFR 866.5660
- Regulation Name: Multiple autoantibodies immunological test system
- Regulatory Class: Class II
- Product Code: NST
- Indications For Use: The IBL Acetylcholine Receptor Antibody (ARAb) Radio Receptor Assay is for the in-vitro diagnostic semi-quantitative determination of autoantibodies against the acetylcholine receptor in human serum and plasma. The ARAb Assay kit is useful as an aid in the differential diagnosis of Myasthenia Gravis (MG).
To provide the requested information, the actual 510(k) submission document, particularly the sections detailing the analytical and clinical performance studies, would be necessary.
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