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510(k) Data Aggregation
(82 days)
COBAS INTEGRA REAGENT CASSETTES
The cassette COBAS INTEGRA x-1-Antitrypsin (AAT) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human x-1-antitrypsin in serum and plasma. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, a-1-antitrypsin deficiency has been associated with pulmonary emphysema.
The cassette COBAS INTEGRA Immunoglobulin A (IGA/IGAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin A in serum and plasma. addition to the standard application (IGA), the sensitive application (IGAP) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin M (IGM/IGMP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin M in serum and plasma. In addition to the standard application (IGM), the sensitive application (IGMP) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin G (Turbidimetric) (IGGT/IGGTC) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin G in serum, plasma (IGGT) and cerebrospinal fluid (IGGTC). Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
Here's a breakdown of the acceptance criteria and study information for the Roche COBAS® INTEGRA Reagent Cassettes for α-1-Antitrypsin (AAT), Immunoglobulin A (IGA/IGAP), and Immunoglobulin M (IGM/IGMP), based on the provided text:
Important Note: The provided document is a 510(k) Summary. This type of summary focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific pre-defined acceptance criteria in the same way a novel device might. The "acceptance criteria" here are inferred from the performance characteristics presented to show equivalence. The studies are primarily comparative studies against predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Roche COBAS® INTEGRA Reagent Cassettes (AAT, IGA/IGAP, IGM/IGMP)
| Performance Characteristic | Acceptance Criteria (inferred from predicate/previous version) | Reported Device Performance (Modified COBAS INTEGRA) | Predicate Device Performance (where available) |
|---|---|---|---|
| α-1-Antitrypsin (AAT) | |||
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., K972640: 0.967 / K954992: 0.930) | 0.995 (vs. BM) | Predicate K972640: 0.967; Cleared K954992: 0.930 |
| Linear Regression | Must be comparable to predicate | 1.30x - 0.31 g/L | Predicate K972640: 0.993x + 9.9 mg/dL; Cleared K954992: 0.90x + 0.06 g/L |
| Immunoglobulin A (IGA/IGAP) | |||
| Precision (IGA) | |||
| Level 1 (Mean ~2.0-2.3 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.9%, Cleared: 1.4%) | 2.0% | Predicate BM: 0.9%; Cleared K954457: 1.4% |
| Level 2 (Mean ~3.5-6.2 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.8%, Cleared: 0.81%) | 0.97% | Predicate BM: 0.8%; Cleared K954457: 0.81% |
| Total CV Level 1 | Total CV comparable to predicate/cleared (e.g., BM: 2.2%, Cleared: 2.8%) | 2.3% | Predicate BM: 2.2%; Cleared K954457: 2.8% |
| Total CV Level 2 | Total CV comparable to predicate/cleared (e.g., BM: 1.8%, Cleared: 1.8%) | 1.2% | Predicate BM: 1.8%; Cleared K954457: 1.8% |
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., BM: 0.99 / Cleared: 0.989) | 0.994 (vs. BM/Hitachi) | Predicate BM: 0.99; Cleared K954457: 0.989 |
| Linear Regression | Must be comparable to predicate | 1.023x - 0.214 g/L | Predicate BM: 0.83x + 20.6 mg/dL; Cleared K954457: 0.97x - 0.05 g/L |
| Assay Range | Must be comparable or improved | 0.45 - 7.3 g/L (std); 0.15 - 98.6 g/L (rerun) | Cleared K954457: 0.79 - 12.6 g/L (std); 0.27 - 30.2 g/L (rerun) |
| Sensitivity | Must be comparable or improved | 0.45 g/L | Cleared K954457: 0.79 g/L |
| Immunoglobulin M (IGM/IGMP) | |||
| Precision (IGM) | |||
| Level 1 (Mean ~0.55-0.6 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.79%, Cleared: 2.6%) | 2.4% | Predicate BM: 0.79%; Cleared K954457: 2.6% |
| Level 2 (Mean ~1.9-2.0 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.8%, Cleared: 2.0%) | 1.6% | Predicate BM: 0.8%; Cleared K954457: 2.0% |
| Total CV Level 1 | Total CV comparable to predicate/cleared (e.g., BM: 3.7%, Cleared: 3.1%) | 3.2% | Predicate BM: 3.7%; Cleared K954457: 3.1% |
| Total CV Level 2 | Total CV comparable to predicate/cleared (e.g., BM: 2.4%, Cleared: 2.2%) | 1.9% | Predicate BM: 2.4%; Cleared K954457: 2.2% |
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., BM: 0.979 / Cleared: 0.994) | 0.994 (vs. BM/Hitachi) | Predicate BM: 0.979; Cleared K954457: 0.994 |
| Linear Regression | Must be comparable to predicate | 1.293x + 0.341 g/L | Predicate BM: 0.81x + 5.9 mg/dL; Cleared K954457: 1.12x - 0.06 g/L |
| Assay Range | Must be comparable or improved | 0.16 - 5.18 g/L (std); 0.05 - 24.35 g/L (rerun) | Cleared K954457: 0.31 - 5.0 g/L (std); 0.11 - 12.1 g/L (rerun) |
| Sensitivity | Must be comparable or improved | 0.16 g/L | Cleared K954457: 0.31 g/L |
2. Sample Sizes Used for the Test Set and Data Provenance
- α-1-Antitrypsin (AAT):
- Sample Size: 288
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
- Immunoglobulin A (IGA/IGAP):
- Sample Size: 584
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
- Immunoglobulin M (IGM/IGMP):
- Sample Size: 556
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic reagent, and the 'ground truth' is established by comparative measurements against predicate devices using laboratory methods, not human expert interpretation of images or clinical cases. The comparison is against established laboratory testing methods.
4. Adjudication Method for the Test Set
Not applicable. The 'test set' here consists of biological samples measured by the device and compared to results from predicate devices/methods. There is no human adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are typically for imaging devices or AI tools that assist human readers in interpretation. This is an IVD reagent, and the effectiveness is evaluated through analytical performance characteristics like accuracy, precision, and linearity when compared to established methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The studies summarized are standalone performance evaluations of the reagent cassette on the COBAS INTEGRA Analyzer. The results are generated by the automated system, without "human-in-the-loop" needing to interpret the primary measurement, although human operators load samples and review results. The comparison is between the modified reagent's performance and that of other established laboratory methods (predicate devices).
7. The Type of Ground Truth Used
The ground truth used for these studies is comparative measurement data from legally marketed predicate devices and established laboratory methods. Specifically:
- AAT: Comparison against Boehringer Mannheim α-1-Antitrypsin Reagent (K972640) and Cleared COBAS INTEGRA α-1-Antitrypsin (K954992). The "vs. BM" implies using the Boehringer Mannheim method as a reference.
- IGA/IGAP: Comparison against Boehringer Mannheim Immunoglobulin A Reagent (K955907) and Cleared COBAS INTEGRA Immunoglobulin A (K954457). The "vs. BM/Hitachi" indicates comparison with these laboratory systems.
- IGM/IGMP: Comparison against Boehringer Mannheim Immunoglobulin M Reagent (K955908) and Cleared COBAS INTEGRA Immunoglobulin M (K954457). The "vs. BM/Hitachi" indicates comparison with these laboratory systems.
8. The Sample Size for the Training Set
Not applicable. These are reagent cassettes used with an existing analyzer. There is no mention of machine learning or AI models with "training sets" in the context of this 510(k) submission. The development and optimization of the reagent formulations and assay parameters would be part of a different internal R&D process, not typically described as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device and submission. The "ground truth" for evaluating the performance of these reagents is established through established analytical chemistry and immunology principles, validated against reference materials, and benchmarked against predicate diagnostic assays.
Ask a specific question about this device
(57 days)
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
COBAS INTEGRA Ammonia (NH3): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045).
COBAS INTEGRA aAmylase EPS (AMYLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999).
COBAS INTEGRA Cholesterol (CHOLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol (test CHOLL, 0-001) and HDL cholesterol concentration in serum and plasma in clinical laboratories.
COBAS INTEGRA HDL Cholesterol Application (HDLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol and HDL - cholesterol (test HDLL, 0-002) concentration in serum and plasma in clinical laboratories.
COBAS INTEGRA Creatinine Enzymatic (CREAE): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the creatinine concentration in serum (test CREAE, 0-014), and urine (test CREEU, 0-114).
COBAS INTEGRA Digitoxin (DIGIT): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of digitoxin in serum or heparinized plasma (test DIGIT 0-259).
COBAS INTEGRA Gamma Glutamyltransferase (GGTL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTL, 0-599).
COBAS INTEGRA Glucose HK Liquid (GLUCL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma (test GLUL, 0-991), urine (test GLULU, 0-992), and cerebrospinal fluid (test GLULC, 0-993).
COBAS INTEGRA Lipase (LIPL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of lipase in serum and plasma (test LIPL, 0-200).
COBAS INTEGRA Lysergic acid diethylamide (LSD) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the qualitative determination of lysergic acid diethylamide (LSD) in urine (test LSD, 0-001)
COBAS INTEGRA Urea/BUN (UREAL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the urea/BUN (blood urea nitrogen), in serum, plasma (test UREL, 0-003) and urine (test URELU, 0-004).
Roche TDM OnLine Digitoxin Calibrators: are intended for use with the Roche reagents for Digitoxin and the COBAS Chemistry systems for the quantitative determination of digitoxin in serum and plasma.
Roche TDM OnLine Digitoxin Controls: are quality control samples intended for use on COBAS chemistry systems with Roche reagents and calibrators for the quantitative determination of digitoxin assays.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8℃. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents. Through this submission, it is the intention of Roche Diagnostic Systems to gain clearance for an additional 4 COBAS INTEGRA Reagent Cassettes and 2 ancillary reagents as well as modifications to 7 previously cleared COBAS INTEGRA Reagent Cassettes. These reagents have been modified from granulate to liquid form.
The provided 510(k) summary (K972250) describes the acceptance criteria and study results for several Roche COBAS INTEGRA Reagent Cassettes and ancillary reagents. The studies are primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a fixed clinical standard. Consequently, the "acceptance criteria" are implied by the results of the comparative studies to be within acceptable analytical performance limits for equivalent devices.
Here's a breakdown of the requested information for each reagent, based on the provided text:
Roche COBAS® INTEGRA Reagent Cassettes & Ancillary Reagents (K972250)
The acceptance criteria are generally implied by the strong correlation and similar performance characteristics (assay range, precision, sensitivity, accuracy/linearity) when compared to the legally marketed predicate devices. The study's goal was to demonstrate substantial equivalence, meaning the new device performs comparably to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these in vitro diagnostic devices are demonstrated through a comparison of their performance characteristics (Assay Range, Precision, Sensitivity, Accuracy/Correlation Coefficient, and Linear Regression) against legally marketed predicate devices. The "reported device performance" is the performance of the COBAS INTEGRA (Liquid) reagents. The "acceptance criteria" are implied to be within comparable ranges to the predicate devices, indicating substantial equivalence.
Note: For each test, the predicate device's performance is presented alongside the new device's performance, and the linear regression typically shows correlation against the predicate. This comparative approach is the core of the acceptance criteria.
Ammonia (NH3)
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (COBAS INTEGRA Ammonia Liquid) |
|---|---|---|
| Assay Range | 0 - 700 U/L (0-2800 U/L with postdilution) | 0 - 700 µmol/L (0-1190 ug/dL) |
| Precision (Level 1) | Mean: ૯દિવ; %CV (within run): 5.7; %CV (total): 8.8 | Mean: 48.8 µmol/L; %CV (w/r): 3.1; %CV (total): 5.2 |
| Precision (Level 2) | Mean: 211; %CV (within run): 1.9; %CV (total): 5.9 | Mean: 226 µmol/L; %CV (w/r): 2.0; %CV (total): 2.5 |
| Sensitivity | 0.0009 AA per µmol/L | 0.76 AA per µmol/L |
| Accuracy (n=164) | Corr. Coefficient (r): 0.992 | Corr. Coefficient (r): 0.997 |
| Lin. Regression | 1.02x + 3.2 µmol/L | 1.03x - 2.8 µmol/L vs. Roche Reagent for Ammonia |
Creatinine (CREAE) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Creatinine (Kinetic, Jaffé)) | Reported Device Performance (COBAS INTEGRA Creatinine (Enzymatic, PAP)) |
|---|---|---|
| Assay Range | 0 - 1300 µmol/L (0-13000 µmol/L with post dilution) | 0 - 2000 µmol/L (0-20000 µmol/L with post dilution) |
| Precision (Level 1) | Mean: 85.5 µmol/L; %CV (w/r): 1.5; %CV (total): 1.9 | Mean: 99.4 µmol/L; %CV (w/r): 1.6; %CV (total): 2.2 |
| Precision (Level 2) | Mean: 624 µmol/L; %CV (w/r): 1.1; %CV (total): 1.5 | Mean: 535 µmol/L; %CV (w/r): 0.88; %CV (total): 1.5 |
| Sensitivity | 8.0 X 10^-5 ΔA/min per µmol/L | 2.2 X 10^-4 ΔA per µmol/L |
| Accuracy (n=238) | Corr. Coefficient (r): 0.999 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 0.87x - 2 µmol/L | 1.08x - 30.6 µmol/L vs. COBAS INTEGRA Creatinine (Jaffé) |
Creatinine (CREAE) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Creatinine (Kinetic, Jaffé)) | Reported Device Performance (COBAS INTEGRA Creatinine (Enzymatic, PAP)) |
|---|---|---|
| Assay Range | 0 - 32.5 mmol/L (0-130 mmol/L with post dilution) | 0 - 40 mmol/L (0-200 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 5.3 mmol/L; %CV (w/r): 1.5 | Mean: 4.1 mmol/L; %CV (w/r): 0.88; %CV (total): 1.1 |
| Precision (Level 2) | Mean: 19 mmol/L; %CV (w/r): 1.0 | Mean: 14.0 mmol/L; %CV (w/r): 0.87; %CV (total): 0.93 |
| Sensitivity | Not specified in labeling | 5.7 X 10^-3 ΔA per mmol/L |
| Accuracy (n=116) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 0.99x - 0.28 mmol/L vs. COBAS INTEGRA Creatinine (Jaffé) |
Digitoxin (DIGIT)
| Performance Characteristic | Acceptance Criteria (Predicate: Abbott TDx/TDxFLx Digitoxin) | Reported Device Performance (COBAS INTEGRA Digitoxin) |
|---|---|---|
| Assay Range | 2.0 - 80 ng/mL | 2.0 - 65 ng/mL |
| Precision (Level 1) | Mean: 7.5 ng/mL; %CV (w/r): 7.05; %CV (total): 10.61 | Mean: 10.4 ng/mL; %CV (w/r): 6.0; %CV (total): 7.4 |
| Precision (Level 2) | Mean: 15.0 ng/mL; %CV (w/r): 4.87; %CV (total): 7.19 | Mean: 19.5 ng/mL; %CV (w/r): 3.9; %CV (total): 4.5 |
| Precision (Level 3) | Mean: 35.0 ng/mL; %CV (w/r): 4.72; %CV (total): 8.46 | Mean: 37.1 ng/mL; %CV (w/r): 3.6; %CV (total): 3.7 |
| Sensitivity | 2.0 ng/mL | 2.0 ng/mL |
| Accuracy (n=232) | Corr. Coefficient (r): 0.967 | Corr. Coefficient (r): 0.973 |
| Lin. Regression | 1.060 + 0.729 ng/mL | 0.945x + 1.19 ng/mL vs. Abbott TDx/TDxFLx Digitoxin |
Lysergic acid diethylamide (LSD)
| Performance Characteristic | Acceptance Criteria (Predicate: Roche Abuscreen RIA for LSD) | Reported Device Performance (COBAS INTEGRA LSD) |
|---|---|---|
| Assay Range | 0 - 1 ng/mL | 0 - 1 ng/mL |
| Precision (Level 1) | Mean: 0.0; %CV (w/r): 0.6 | Mean (O.D.): 0.978; %CV (w/r): N/A |
| Precision (Level 2) | Mean: 0.25; %CV (w/r): 1.3 | Mean (O.D.): 0.913; %CV (w/r): N/A |
| Precision (Level 3) | Mean: 0.5; %CV (w/r): 1.6 | Mean (O.D.): 0.870; %CV (w/r): N/A |
| Sensitivity | 0.25 ng/mL of LSD at > 99% confidence | 0.10 ng/mL of LSD at > 95% confidence |
| Accuracy | Positive Samples (GC/MS): 21/0; Positive Samples (RIA): 21/0 | Positive Samples (GC/MS): 39/0; Positive Samples (RIA): 39/0 |
Note: For LSD, precision is presented in Optical Density (O.D.) for the new device vs. ng/mL for the predicate, making direct comparison of mean values challenging. However, the %CV for within-run are similar.
α-Amylase (AMYLL) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA α-Amylase (Granulate)) | Reported Device Performance (COBAS INTEGRA α-Amylase EPS (Liquid)) |
|---|---|---|
| Assay Range | 0 - 2000 U/L (0-20000 U/L with post dilution) | 0 - 2000 U/L (0-10000 U/L with post dilution) |
| Precision (Level 1) | Mean: 143 U/L; %CV (w/r): 1.6; %CV (total): 1.6 | Mean: 76 U/L; %CV (w/r): 1.6; %CV (total): 2.3 |
| Precision (Level 2) | Mean: 277 U/L; %CV (w/r): 1.1; %CV (total): 2.0 | Mean: 498 U/L; %CV (w/r): 1.3; %CV (total): 2.6 |
| Sensitivity | 1.5 X 10^-4 ΔA/min per U/L | 1.9 X 10^-4 ΔA/min per U/L |
| Accuracy (n=114) | Corr. Coefficient (r): 0.992 | Corr. Coefficient (r): 0.996 |
| Lin. Regression | 0.98x - 19 U/L | 0.43x + 4 U/L vs. COBAS INTEGRA α-Amylase (granulate) |
α-Amylase (AMYLL) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA α-Amylase (Granulate)) | Reported Device Performance (COBAS INTEGRA α-Amylase EPS (Liquid)) |
|---|---|---|
| Assay Range | 0 - 2000 U/L (0-20000 U/L with post dilution) | 0 - 2000 U/L (0-10000 U/L with post dilution) |
| Precision (Level 1) | Mean: 22 U/L; %CV (w/r): 2.5 | Mean: 183 U/L; %CV (w/r): 1.3; %CV (total): 1.7 |
| Precision (Level 2) | Mean: 302 U/L; %CV (w/r): 0.56 | Mean: 603 U/L; %CV (w/r): N/A; %CV (total): 1.6 |
| Sensitivity | Not specified in labeling | 1.9 X 10^-4 ΔA/min per U/L |
| Accuracy (n=150) | Not specified in labeling | Corr. Coefficient (r): 0.988 |
| Lin. Regression | Not specified in labeling | 0.44x + 0 U/L vs. COBAS INTEGRA α-Amylase (granulate) |
Cholesterol (CHOLL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Cholesterol (Granulate)) | Reported Device Performance (COBAS INTEGRA Cholesterol (Liquid)) |
|---|---|---|
| Assay Range | 0 - 20.7 mmol/L (0-8000 mg/dL with post dilution) | 0 - 18.1 mmol/L (0-7000 mg/dL with post dilution) |
| Precision (Level 1) | Mean: 5.0 mmol/L; %CV (w/r): 1.3; %CV (total): 1.1 | Mean: 5.3 mmol/L; %CV (w/r): 1.3; %CV (total): 2.2 |
| Precision (Level 2) | Mean: 6.3 mmol/L; %CV (w/r): 1.0; %CV (total): 1.2 | Mean: 6.7 mmol/L; %CV (w/r): 1.1; %CV (total): 2.5 |
| Precision (Level 3) | Mean: 8.0 mmol/L; %CV (w/r): 2.0; %CV (total): 1.5 | N/A |
| Sensitivity | 6.4 X 10^-2 ΔA per mmol/L | 8.8 X 10^-2 ΔA per mmol/L |
| Accuracy (n=214) | Corr. Coefficient (r): 0.995 | Corr. Coefficient (r): 0.998 |
| Lin. Regression | 1.04x + 0.1 mmol/L | 0.99x + 0.0 mmol/L vs. COBAS INTEGRA Cholesterol (granulate) |
HDL-Cholesterol Application (HDLL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA HDL - Cholesterol Application (granulate)) | Reported Device Performance (COBAS INTEGRA HDL - Cholesterol Application (liquid)) |
|---|---|---|
| Assay Range | 0 - 5.0 mmol/L (0-193 mg/dL) | 0 - 5.0 mmol/L (0-193 mg/dL) |
| Precision (Level 1) | Mean: 0.82 mmol/L; %CV (w/r): 1.2; %CV (total): 2.7 | Mean: 0.20 mmol/L; %CV (w/r): 1.51.3*; %CV (total): 3.0 |
| Precision (Level 2) | Mean: 1.42 mmol/L; %CV (w/r): 0.85; %CV (total): 5.5 | Mean: 1.91 mmol/L; %CV (w/r): 0.26; %CV (total): 1.6 |
| Sensitivity | 6.4 X 10^-2 ΔA per mmol/L | 8.8 X 10^-2 ΔA per mmol/L |
| Accuracy (n=240) | Corr. Coefficient (r): 0.998 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 0.99x - 0.05 mmol/L | 0.99x + 0.03 mmol/L vs. COBAS INTEGRA HDL - Cholesterol Application (granulate) |
Note: There seems to be a typo for %CV (within run) in Level 1 of the HDLL liquid reagent (1.51.3).
Gamma-Glutamyltransferase (GGTL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA GGT (Granulate)) | Reported Device Performance (COBAS INTEGRA GGTL (Liquid)) |
|---|---|---|
| Assay Range | 0 - 700 U/L (0-7000 U/L with post dilution) | 0 - 600 U/L (0-6000 U/L with post dilution) |
| Precision (Level 1) | Mean: 37.9 U/L; %CV (w/r): 0.67; %CV (total): 1.2 | Mean: 21 U/L; %CV (w/r): 0.83; %CV (total): 2.8 |
| Precision (Level 2) | Mean: 345 U/L; %CV (w/r): 0.46; %CV (total): 1.4 | Mean: 428 U/L; %CV (w/r): 0.54; %CV (total): 1.5 |
| Sensitivity | 5.0 X 10^4 ΔA/min per U/L | 6.8 X 10^4 ΔA/min per U/L |
| Accuracy (n=196) | Corr. Coefficient (r): 0.998 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 1.00x + 0 U/L | 1.00x - 1.2 U/L vs. COBAS INTEGRA GGTL (granulate) |
Glucose (GLUCL) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Glucose (Granulate)) | Reported Device Performance (COBAS INTEGRA Glucose (Liquid)) |
|---|---|---|
| Assay Range | 0 - 40 mmol/L (0-400 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 5.6 mmol/L; %CV (w/r): 1.2; %CV (total): 1.1 | Mean: 5.3 mmol/L; %CV (w/r): 1.7; %CV (total): 2.6 |
| Precision (Level 2) | Mean: 19.7 mmol/L; %CV (w/r): 0.97; %CV (total): 0.89 | Mean: 33.2 mmol/L; %CV (w/r): 0.72; %CV (total): 1.5 |
| Sensitivity | 9.3 X 10^-2 ΔA per mmol/L | 5.4 X 10^-2 ΔA per mmol/L |
| Accuracy (n=220) | Corr. Coefficient (r): 0.997 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 0.98x + 0.1 mmol/L | 1.05x - 0.2 mmol/L vs. COBAS INTEGRA Glucose (granulate) |
Glucose (GLUCL) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Glucose (Granulate)) | Reported Device Performance (COBAS INTEGRA Glucose (Liquid)) |
|---|---|---|
| Assay Range | 0 - 16 mmol/L (0-160 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 0.27 mmol/L; %CV (w/r): 2.0 | Mean: 1.7 mmol/L; %CV (w/r): 1.7; %CV (total): 4.3 |
| Precision (Level 2) | Mean: 0.48 mmol/L; %CV (w/r): 0.99 | Mean: 37.1 mmol/L; %CV (w/r): 1.8; %CV (total): 2.9 |
| Sensitivity | 2.2 X 10^1 ΔA per mmol/L | 5.4 X 10^2 ΔA per mmol/L |
| Accuracy (n=120) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 1.01x - 0.02 mmol/L vs. COBAS INTEGRA Glucose (granulate) |
Glucose (GLUCL) - CSF
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Glucose (Granulate)) | Reported Device Performance (COBAS INTEGRA Glucose (Liquid)) |
|---|---|---|
| Assay Range | 0 - 20 mmol/L (0-360 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 4.7 mmol/L; %CV (w/r): 0.57 | Mean: 1.7 mmol/L; %CV (w/r): 1.6; %CV (total): 2.3 |
| Precision (Level 2) | Mean: 10.3 mmol/L; %CV (w/r): 0.23 | Mean: 3.3 mmol/L; %CV (w/r): 1.8; %CV (total): 1.9 |
| Sensitivity | 1.8 X 10^1 ΔA per mmol/L | 5.4 X 10^2 ΔA per mmol/L |
| Accuracy (n=212) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 1.02x - 0.17 mmol/L vs. COBAS INTEGRA Glucose (granulate) |
Lipase (LIPL)
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Lipase (Granulate)) | Reported Device Performance (COBAS INTEGRA Lipase (Liquid)) |
|---|---|---|
| Assay Range | 0 - 700 U/L (0-3500 U/L with post dilution) | 0 - 600 U/L (0-3000 U/L with post dilution) |
| Precision (Level 1) | Mean: 116 U/L; %CV (w/r): 1.7; %CV (total): 4.6 | Mean: 126 U/L; %CV (w/r): 1.9; %CV (total): 3.1 |
| Precision (Level 2) | Mean: 550 U/L; %CV (w/r): 2.1; %CV (total): 3.7 | Mean: 515 U/L; %CV (w/r): 1.3; %CV (total): 2.9 |
| Sensitivity | 5.6 X 10^-5 ΔA/min per U/L | 6.4 X 10^-5 ΔA/min per U/L |
| Accuracy (n=198) | Corr. Coefficient (r): 0.976 | Corr. Coefficient (r): 0.976 |
| Lin. Regression | 1.06x - 7 U/L | 0.82x + 16 U/L vs. COBAS INTEGRA Lipase (granulate) |
Urea/BUN (UREAL) - Serum and Plasma
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Urea/BUN (Granulate)) | Reported Device Performance (COBAS INTEGRA Urea/BUN (Liquid)) |
|---|---|---|
| Assay Range | 0 - 55 mmol/L (0-550 mmol/L with post dilution) | 0 - 40 mmol/L (0-400 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 6.9 mmol/L; %CV (w/r): 0.85; %CV (total): 2.0 | Mean: 4.1 mmol/L; %CV (w/r): 2.3; %CV (total): 3.9 |
| Precision (Level 2) | Mean: 19.9 mmol/L; %CV (w/r): 1.0; %CV (total): 2.3 | Mean: 31.0 mmol/L; %CV (w/r): 0.89; %CV (total): 2.8 |
| Sensitivity | 6.8 X 10^-3 ΔA/min per mmol/L | 2.2 X 10^-2 ΔA/min per mmol/L |
| Accuracy (n=236) | Corr. Coefficient (r): 0.999 | Corr. Coefficient (r): 0.999 |
| Lin. Regression | 1.01x + 0.30 mmol/L | 1.00x + 0.1 mmol/L vs. COBAS INTEGRA Urea/BUN (granulate) |
Urea/BUN (UREAL) - Urine
| Performance Characteristic | Acceptance Criteria (Predicate: COBAS INTEGRA Urea/BUN (Granulate)) | Reported Device Performance (COBAS INTEGRA Urea/BUN (Liquid)) |
|---|---|---|
| Assay Range | 0 - 2200 mmol/L (0-5500 mmol/L with post dilution) | 0 - 2000 mmol/L (0-6000 mmol/L with post dilution) |
| Precision (Level 1) | Mean: 73 mmol/L; %CV (w/r): 0.99 | Mean: 421 mmol/L; %CV (w/r): 1.3; %CV (total): 1.8 |
| Precision (Level 2) | Mean: 345 mmol/L; %CV (w/r): 0.6 | Mean: 679 mmol/L; %CV (w/r): 1.2; %CV (total): 1.8 |
| Sensitivity | Not specified in labeling | 2.0 X 10^-2 ΔA/min per mmol/L |
| Accuracy (n=120) | Not specified in labeling | Corr. Coefficient (r): 0.999 |
| Lin. Regression | Not specified in labeling | 1.0X + 1.3 mmol/L vs. COBAS INTEGRA Urea/BUN (granulate) |
2. Sample sizes used for the test set and data provenance
The sample sizes for accuracy/correlation studies are provided in the tables above under "Sample size (n)". These values range from 114 to 240 for quantitative assays and 39 (positive) for LSD.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, given the context of a 510(k) submission for in vitro diagnostic reagents by Roche Diagnostic Systems, Inc. (located in Somerville, New Jersey, USA), it is highly likely these studies were conducted in a clinical laboratory setting in the USA. The studies are presented as direct comparisons between the new liquid reagents and existing granulate reagents or other legally marketed devices, implying they are prospective comparative studies assessing analytical performance.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
For these chemical assays (e.g., ammonia, creatinine, cholesterol) and therapeutic drug monitoring (digitoxin), "ground truth" is typically established by the quantitative results of the predicate device or a reference method. The document does not mention "experts" in the sense of human readers adjudicating results, as these are quantitative in vitro diagnostic tests. The ground truth is the measured concentration or activity of the analyte as determined by the accepted reference method or predicate device functionality.
For LSD, which involves qualitative detection, the "ground truth" against which the COBAS INTEGRA LSD was compared appears to be GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug detection. The document does not specify the qualifications of individuals performing these GC/MS analyses or interpreting the results, but they would be trained laboratory personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned. For these types of quantitative and qualitative analytical tests, "adjudication" by experts in the context of diagnostic imaging or pathology interpretation is not applicable. The comparison is based on numerical results compared to an established method or predicate.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was conducted. This type of study is relevant for medical imaging or pathology devices where human interpretation is a key component, often assisted by AI. The submitted devices are reagents for automated clinical analyzers, where the output is a numerical value or a qualitative positive/negative result, not an image requiring human interpretation. Therefore, there's no mention of AI assistance or human reader improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are effectively standalone performance evaluations of the reagent-analyzer system. These are not "algorithm-only" studies in the modern AI sense, but rather a direct assessment of the analytical performance of the new liquid reagent format on the COBAS INTEGRA Analyzer. The results (e.g., assay range, precision, accuracy) reflect the performance of the integrated system without direct human-in-the-loop interpretation impacting the primary measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used varies slightly based on the assay, but generally involves:
- Quantitative Assays (Ammonia, Creatinine, Cholesterol, HDL-Cholesterol, GGT, Glucose, Lipase, Urea/BUN): The ground truth for these assays is the quantitative result obtained from the predicate device method. The accuracy is assessed by correlating the results of the new liquid reagents with the predicate (often the granulate version of the same Roche COBAS INTEGRA reagents or another established method like Abbott TDx/TDxFLx for Digitoxin). Linear regression analysis is used to demonstrate agreement.
- Qualitative Assay (LSD): The ground truth for LSD detection is established by a more definitive analytical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS).
8. The sample size for the training set
The document does not explicitly delineate a "training set" in the context of machine learning or AI development. For these chemical assays, the development of the reagents and their formulation would involve extensive R&D and optimization, which could be considered an iterative development process, but it's not described as a distinct "training set" with separate ground truth establishment. The data presented in the tables are for validation or verification of the final product.
9. How the ground truth for the training set was established
As there is no explicitly defined "training set" in the submitted documentation related to AI/ML, there is no description of how ground truth for such a set was established. The development of reagents relies on established chemical and biochemical principles, and performance characteristics are determined through standard analytical validation procedures using reference materials and comparative studies against predicate methods.
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(71 days)
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
Through this submission, it is the intention of Roche to gain clearance of an additional 4 COBAS Reagent Cassettes and 6 ancillary reagents. These are the COBAS INTEGRA Cassette for Antithrombin III, COBAS INTEGRA Cassette for Ferritin, COBAS INTEGRA Cassette for Myoglobin, COBAS INTEGRA Cassette for Rheumatoid Factors, Roche Plasmachrom Calibrator, Roche Plasmachrom N & P Controls, Roche FERR T Standard, Roche FERR/MYO T Control, Roche MYOT Standard, and Roche RF Standard II. The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYOT Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Calcium. The performance of the COBAS INTEGRA Reagent Cassette for Calcium has been improved due to the use of new instrument parameters.
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
The provided text describes several COBAS INTEGRA Reagent Cassettes and ancillary reagents. Each product has its own performance characteristics detailed in separate tables comparing it to a predicate device. I will break down the acceptance criteria and study information for each of the primary assay cassettes.
General Information Applicable to All Devices:
- Data Provenance: Not explicitly stated, but clinical and non-clinical studies are mentioned. It is implicitly retrospective as it compares performance to predicate devices and existing methodologies.
- Number of experts used to establish ground truth & qualifications: Not specified.
- Adjudication method: Not specified.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as these are diagnostic assays, not image-based AI systems involving human readers.
- Standalone (algorithm only) performance: This is the core of the evaluation for these devices, as they are automated diagnostic assays.
- Type of ground truth: For accuracy, the ground truth is established by correlation to a legally marketed predicate device or a clinical method (e.g., enzyme immunoassay, radioimmunoassay).
1. COBAS INTEGRA Cassette for Antithrombin III
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Berichrom AT III) | Reported Device Performance (COBAS INTEGRA AT III) |
|---|---|---|
| Assay Range | 0-140% | 0-150% |
| Precision (Day-to-day) | Normal plasma: 1.0-2.5% | 4.1% at 51.9% |
| Pathological plasma: 1.5-3.0% | 2.8% at 105.7% | |
| Accuracy (R-value) | > 0.95 vs. Berichrom Reagent | R = 0.973 vs. Berichrom Reagent |
| Sensitivity (Analytical) | Not specified in labeling | 1.6 X 10⁻³ ΔA/min per % change in AT III activity |
Study Details:
- Sample size for test set: N = 200 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
2. COBAS INTEGRA Cassette for Ferritin
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Behring N Latex Ferritin) | Reported Device Performance (COBAS INTEGRA Ferritin) |
|---|---|---|
| Assay Range | 5-320 ug/L | 0-300 ug/L (0-3000 ug/L with postdilution) |
| Precision (Within-run) | 3.8% at 5 ug/L | |
| 1.5% at 15 ug/L | 9.9 % at 19 ug/L | |
| 1.2 % at 260 ug/L | ||
| Accuracy (Regression) | y = 0.80x + 2.9 ug/L vs.behring N Latex Ferritin; |
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COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
The 2 COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. These are the COBAS INTEGRA Cassette for Albumin-T in urine and the COBAS INTEGRA Cassette for HbA1c. The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine. The COBAS INTEGRA Cassette for Hemoglobin Alc contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbAlc%) in hemolysate. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Digoxin. The COBAS INTEGRA Reagent Cassette for Digoxin has been modified to include the use of heparinized samples.
The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8ºC. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number, the expiration date and the number of tests.
Here's an analysis of the provided text, focusing on the requested information regarding acceptance criteria and supporting studies:
This document describes the 510(k) summary for Roche COBAS® INTEGRA Reagent Cassettes, specifically for Albumin (ALB-T), HbA1c, and a modification to Digoxin (DIG), claiming substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Device/Parameter | Acceptance Criteria (Implied/Predicate) | COBAS INTEGRA Performance (New Device) |
|---|---|---|
| COBAS INTEGRA Albumin (ALB-T) | ||
| Methodology | Immunoturbidimetric | Immunoturbidimetric |
| Sample type | Serum, umbilical cord serum, CSF, urine | Urine |
| Assay range | Not specified in labeling | 6-193 mg/L; 6-3860 mg/L w/postdilution |
| Precision (Within-run) | Not specified in labeling | 4.3 % at 10 mg/L; 1.2 % at 223 mg/L |
| Accuracy | Not specified in labeling | N = 200; R = 0.997 vs. Behring Albumin (Predicate device: Behring N Antiserum to Human Albumin) |
| Sensitivity (Analytical) | Not specified in labeling | 7 mg/L |
| COBAS INTEGRA HbA1c (HBA1C) | ||
| Methodology | Immunoturbidimetric for HbA1c; Colorimetric for Total Hb | Immunoturbidimetric test for HbA1c; Colorimetric test for Total Hb |
| Sample type | Anticoagulated venous or capillary whole blood (heparin, EDTA, citrate or oxalate/fluoride) | Anticoagulated venous or capillary whole blood (heparin, EDTA, citrate or oxalate/fluoride) |
| Application | Hemolysate or whole blood | Hemolysate |
| Reported measuring units | % HbA1c | % HbA1c |
| Assay range | 2-25 % | 3-30.9 % |
| Precision (Total) | Mean % CV %: 5.3 % (5.3%); 12.9 % (4.9%) (Predicate device: Roche Unimate HbA1c Reagent) | Mean % CV %: 4.8 % (2.8%); 12.1 % (2.4%) |
| Accuracy | N = 208; R = 0.943 vs. BM Tina-quant HbA1c Reagent | N = 240; R = 0.994 vs. Roche Unimate Reagent (Predicate device: Roche Unimate HbA1c Reagent) |
| Sensitivity (Analytical) | 0.76 umol/L for hemoglobin; 0.78 umol/L for HbA1c | 0.90 umol/L for hemoglobin; 0.22 umol/L for HbA1c |
| COBAS INTEGRA Digoxin (Modified) | ||
| Methodology | Kinetic interaction of microparticles in solution | Kinetic interaction of microparticles in solution |
| Sample type | Serum | Serum and heparinized plasma |
| Assay range | 0.17 - 5.0 ng/mL | 0.17 - 5.0 ng/mL |
| Precision (Total) | 14.4 % at 0.81 ng/mL; 5.3 % at 1.57 ng/mL; 3.8 % at 4.1 ng/mL (Predicate device: COBAS INTEGRA Cassette for Digoxin - Cleared) | 9.7 % at 0.87 ng/mL; 6.1 % at 1.64 ng/mL; 3.9 % at 2.82 ng/mL |
| Accuracy | N = 189; R = 0.958 vs. TDx (FPIA) | N = 63; R = 0.967 vs. TDx (FPIA) (Predicate device: COBAS INTEGRA Cassette for Digoxin - Cleared) |
| Sensitivity (Analytical) | 0.17 ng/mL | 0.17 ng/mL |
Note on Acceptance Criteria: The document primarily relies on demonstrating substantial equivalence to predicate devices, rather than explicit numerical acceptance criteria for the new devices. The "performance characteristics" of the predicate devices implicitly serve as the benchmark for comparability. For the Digoxin modification, the cleared COBAS INTEGRA Cassette for Digoxin serves as its own predicate and its performance metrics represent the baseline for the modification.
2. Sample Sizes Used for the Test Set and Data Provenance
- COBAS INTEGRA Albumin (ALB-T):
- Accuracy: N = 200 samples.
- Data Provenance: Not explicitly stated, but clinical and nonclinical studies are mentioned. It's likely a mix of laboratory-generated samples and potentially clinical samples from various sources. The document does not specify country of origin or whether prospective/retrospective.
- COBAS INTEGRA HbA1c (HBA1C):
- Accuracy: N = 240 samples.
- Data Provenance: Not explicitly stated beyond "clinical and nonclinical studies."
- COBAS INTEGRA Digoxin (Modified):
- Accuracy: N = 63 samples.
- Data Provenance: Not explicitly stated beyond "clinical and nonclinical studies."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission is for in vitro diagnostic reagents and an analyzer system. The "ground truth" for such devices is established through reference methods or comparison to legally marketed predicate devices, not through expert radiological or clinical interpretation in the traditional sense. Therefore:
- Number of Experts: Not applicable in the context of expert consensus like for imaging devices. Ground truth is inherently derived from the analytical performance of the reference method.
- Qualifications of Experts: Not applicable. The "experts" are the validated methodologies of the predicate devices or reference methods.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments to resolve discrepancies. For in vitro diagnostic assays, the comparison is quantitative against a reference method or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems where human readers interpret cases, often with and without AI assistance to measure the impact of AI on reader performance. This submission is for laboratory reagents and an analyzer, where the output is quantitative and direct, not an interpretation by a human reader.
- Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Was it done?: Yes, the performance characteristics (assay range, precision, accuracy, sensitivity) presented in Tables 1-3 represent the standalone performance of the COBAS INTEGRA Reagent Cassettes when used with the COBAS INTEGRA Analyzer. There is no human-in-the-loop component for these specific assays; the analyzer performs the test and provides the quantitative result directly. The study essentially demonstrates the algorithm and instrument's performance in producing these quantitative values.
7. Type of Ground Truth Used
The ground truth for these in vitro diagnostic tests is established by:
- For Albumin and HbA1c: Performance against a legally marketed predicate device (Behring N Antiserum to Human Albumin for Albumin, and Roche Unimate HbA1c Reagent for HbA1c). The reference standard for "accuracy" is the results obtained from these predicate devices.
- For Digoxin (Modified): Performance against the previously cleared COBAS INTEGRA Cassette for Digoxin and comparison to TDx (FPIA), which is likely a well-established and accepted reference method for Digoxin measurement.
8. Sample Size for the Training Set
The document does not specify a training set size. For a 510(k) submission detailing reagent cassettes, particularly for established immunological/colorimetric methods, the focus is on validation and verification of the final product's performance against predicate devices or reference methods. The "training" of an AI algorithm in the modern sense is not applicable here, as these are chemical/biological assays, not machine learning algorithms in the typical AI context. The document describes clinical and nonclinical studies and performance characteristics, which refer to the validation data for the device.
9. How the Ground Truth for the Training Set was Established
As explained above, the concept of a "training set" and associated ground truth establishment (in the AI/ML sense) is not applicable to this type of in vitro diagnostic device submission, which relies on chemical/biological reactions and analytical performance validation rather than machine learning algorithm development. The "ground truth" for analytical performance is established by comparison to recognized reference methods or existing, legally marketed predicate devices.
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ROCHE COBAS INTEGRA REAGENT CASSETTES
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