(147 days)
The Bayer Advia IMS Direct Bilirubin assay is an in virro diagnostic device intended to measure conjugated bilirubin in human serum or plasma. Measurements of direct or total bilirubin organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.
The Bayer Advia IMS Hemoglobin A1c (HbA1c) method is an in vitro diagnostic device intended to measure Hemoglobin A1c, a diabetes marker, in human blood. Measurements of HbAlc can bc used for monitoring the long term care of persons with diabetes. The HbAlc and total hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA 1c/THb ratio, and must not be used individually for diagnostic purposes.
The Bayer Advia IMS Gentamicin assay is an in vitro diagnostic device intended to measure gentamicin, an antibiotic drug, in human serum. Measurements of gentamicin are used as an aid in the diagnosis and treatment of gentamicin overdose and in monitoring therapeutic levels of gentamicin to ensure appropriate therapy.
The Bayer Advia IMS Magnesium method is an in vitro diagnostic device intended to measure magnesium in human serum, plasma or urine. Measurements of magnesium are used in the diagnosis and treatment of hypomagnesemia, hypermagnesemia and monitoring of patients receiving prolonged magnesium-free intravenous therapv.
The Bayer Advia IMS Theophylline assay is an in vitro diagnostic device intended to measure theophylline in human serum. Measurements of theophyllinc arc used as an aid in the diagnosis and treatment theophylline overdose and in monitoring therapeutic levels of theophylline to ensure appropriate therapy.
The Bayer Advia IMS Tobramvoin assay is an in vitro diagnostic device intended to quantitatively measure tobramycin, an antibiotic drug, human serum. Measurements of tobramycin are used in the diagnosis and treatment of tobramycin overdose and in monitoring therapeutic levels of tobramycin to ensure appropriate therapy.
The Bayer Advia IMS Uric Acid (UA) method is an in vitro diagnostic device intended to measure uric acid in human serum, plasma, and urine. Such measurements are used as an aid in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, and of patients receiving cytotoxic drugs.
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Here's a breakdown of the acceptance criteria and supporting studies for each of the devices mentioned in the provided 510(k) summaries. It's important to note that these documents are primarily for demonstrating substantial equivalence to a predicate device, which often means showing comparable performance rather than setting strict, pre-defined "acceptance criteria" against an absolute standard. The "reported device performance" is essentially the data presented to demonstrate this equivalence.
For all devices, the data provenance is assumed to be retrospective as these are 510(k) summaries, typically presented after studies have been completed. The country of origin for the data is not explicitly stated but can be inferred as the "Bayer Corporation, Business Group Diagnostics Tarrytown, NY" is the submitter.
General Caveats for all devices:
- Sample Size for Training Set: The documents do not provide information on the sample size or ground truth establishment for any training sets. This is typical for 510(k) summaries of in vitro diagnostic assays, which often focus on analytical performance rather than machine learning algorithm development.
- Number of Experts & Qualifications / Adjudication Method / MRMC Comparative Effectiveness Study / Standalone Performance: These concepts are not applicable to the analytical performance testing of in vitro diagnostic assays described in these summaries. These are typically relevant for image-based diagnostic AI/ML devices where reader interpretation is a key component. The "ground truth" for these assays is the reference method's result, or values from a highly characterized reference material.
1. Direct Bilirubin method for ADVIA® 400 (K993867)
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA 400) |
|---|---|---|
| Imprecision (CV%) | Level 0.7 mg/dL: 9.0% CV | |
| Level 0.7-1.0 mg/dL | Similar to predicate (e.g., 0.95) | 0.994 |
| Sample Range | Appropriate for clinical use | 0.0 - 10.6 mg/dL |
| Matrix Comparison (Plasma vs. Serum) | ||
| Regression Equation (Y=Plasma, X=Serum) | Slope close to 1, Intercept close to 0 | Y=0.89X+0.06 |
| Syx (mg/dL) | Low | 0.03 |
| r (correlation coefficient) | Close to 1 | 0.852 |
| Sample Range | Appropriate for clinical use | 0.09 - 0.42 mg/dL |
| Interference | Minimal clinical impact | Hemoglobin (500 mg/dL): -17% effect @ 0.9 mg/dL D. Bilirubin |
| Lipids (Triglycerides 500 mg/dL): -69% effect @ 1.8 mg/dL D. Bilirubin | ||
| Analytical Range | Clinically relevant | 0 to 14 mg/dL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- Imprecision (CV%): Not explicitly stated, typically involves replicate measurements of controls or pooled samples.
- Correlation (Serum vs. CHEM 1): N=59
- Correlation (Plasma vs. Serum): N=59
- Interfering Substances: Not explicitly stated, typically involves a few samples spiked with interferents.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- Imprecision: Measured value from the ADVIA 400 system itself, demonstrating repeatability.
- Correlation: The comparison system (Technicon CHEM 1) is used as the reference/ground truth for the test.
- Interfering Substances: The true concentration of D. Bilirubin in the sample prior to adding the interferent.
- Analytical Range: Established by demonstrating linearity and acceptable recovery across the stated range, with reference materials or spiked samples.
2. HbA1c Method for ADVIA IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate | 0.61% |
| Imprecision (CV%) | Level 5.71%: 5.4% CV | |
| Level 4.6-5.71% | Similar to predicate (e.g., 0.95) | 0.991 |
| Sample Range | Appropriate for clinical use | 5.09 - 17.21 % |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): -1% effect |
| Bilirubin (conjugated 20 mg/dL): -2% effect | ||
| Urea (500 mg/dL): +4% effect | ||
| Lipids (Triglycerides 1000 mg/dL): -4% effect | ||
| Analytical Range | Clinically relevant | 0.61 to 17.2% |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated, typically involves multiple measurements of low-concentration samples.
- Imprecision (CV%): Not explicitly stated, usually multiple replicates across different runs/days.
- Correlation (Serum vs. RA-1000): N=57
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer RA-1000 HbAlc) is used as the reference/ground truth.
- Interfering Substances: The true concentration of HbA1c in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known HbA1c concentrations.
3. Gentamicin Method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate | 0.06 µg/mL |
| Imprecision (CV%) | Level 1.79 µg/mL: 7.2% CV | |
| Level 1.79-3.20 µg/mL | Similar to predicate (e.g., 0.95) | 0.989 |
| Sample Range | Appropriate for clinical use | 0.5 - 11.5 µg/mL |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): +3% effect |
| Bilirubin (conjugated 20 mg/dL): +3% effect | ||
| Hemoglobin (600 mg/dL): -4% effect | ||
| Lipids (Triglycerides 1000 mg/dL): +4% effect | ||
| Analytical Range | Clinically relevant | 0.06 to 16.0 µg/mL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. Immuno 1): N=54
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer Immuno 1 Gentamicin) is used as the reference/ground truth.
- Interfering Substances: The true concentration of Gentamicin in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Gentamicin concentrations.
4. Magnesium method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Serum CV%) | Level 1.76 mg/dL: 2.4% CV | |
| Level 1.6-1.76 mg/dL | Similar to predicate (e.g., 0.95) | 0.991 |
| Sample Range | Appropriate for clinical use | 4.1 - 39.6 µg/mL |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): +6% effect |
| Bilirubin (conjugated 15 mg/dL): +7% effect | ||
| Hemoglobin (600 mg/dL): -4% effect | ||
| Lipids (Triglycerides 1000 mg/dL): -6% effect | ||
| Analytical Range | Clinically relevant | 0.47 to 40 µg/mL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. RA-1000): N=51
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer RA-1000 Theophylline) is used as the reference/ground truth.
- Interfering Substances: The true concentration of Theophylline in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Theophylline concentrations.
6. Tobramycin Method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Minimum Detectable Concentration (MDC) | Lower than or comparable to predicate | 0.34 µg/mL |
| Imprecision (CV%) | Level 1.92 µg/mL: 4.3% CV | |
| Level 1.15-1.92 µg/mL | Similar to predicate (e.g., 0.95) | 0.997 |
| Sample Range | Appropriate for clinical use | 0.3 - 11.5 µg/mL |
| Interference | Minimal clinical impact | Bilirubin (unconjugated 25 mg/dL): +6% effect |
| Bilirubin (conjugated 20 mg/dL): +3% effect | ||
| Hemoglobin (600 mg/dL): 0% effect | ||
| Lipids (Triglycerides 1000 mg/dL): -1% effect | ||
| Analytical Range | Clinically relevant | 0.34 to 16.0 µg/mL |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Sizes:
- MDC: Not explicitly stated.
- Imprecision (CV%): Not explicitly stated.
- Correlation (Serum vs. Immuno 1): N=69
- Interfering Substances: Not explicitly stated.
- Data Provenance: Retrospective, country of origin not explicitly stated (implied USA).
7. The type of ground truth used
- MDC: Determined by statistical analysis of repeat measurements of blank or low-level samples.
- Imprecision: Measured value from the ADVIA IMS system itself.
- Correlation: The comparison system (Bayer Immuno 1 Tobramycin) is used as the reference/ground truth.
- Interfering Substances: The true concentration of Tobramycin in the sample prior to adding the interferent.
- Analytical Range: Established using materials with known Tobramycin concentrations.
7. Uric Acid method for ADVIA® IMS
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Serum CV%) | Level 3.68 mg/dL: 3.6% CV | |
| Level 3.68-3.8 mg/dL | Similar to predicate (e.g., |
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.