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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

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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