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K Number
K964506
Device Name
ROCHE COBAS AMPLICOR ANALYZER
Manufacturer
ROCHE MOLECULAR SYSTEMS, INC.
Date Cleared
1997-05-21

(194 days)

Product Code
JJF
Regulation Number
862.2170
Type
Traditional
Panel
CH
Reference & Predicate Devices
K950104,K940390
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The COBAS AMPLICOR Analyzer is an in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures.

Device Description

The COBAS AMPLICOR is a flexible, automated bench top batch analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS AMPLICOR combines the operations of automated sample handling, reagents deliver, thermal cycling, controlled temperature incubation, photometric detection and result reporting into a single automated analyzer. The instrument consists of five major sub-components: (1) a thermal cycler module; (2) an automated pipeting station; (3) an incubation station; (4) a wash station; and (5) a photometer. An internal computer controls and monitors the major components includingsystem and run control, input/output, communication, results calculaton, and system diagnostic tests.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the COBAS AMPLICOR™ Analyzer, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical targets (e.g., minimum sensitivity or specificity values). Instead, the primary acceptance criteria focused on demonstrating substantial equivalence to an existing, legally marketed device, particularly the Roche AMPLICOR Chlamydia trachomatis Test performed with separate components. The performance characteristics were evaluated through a precision study and a clinical comparison study.

The core claim is that the COBAS AMPLICOR Analyzer, when used with the COBAS AMPLICOR Chlamydia trachomatis Test, performs equivalently to the manual AMPLICOR Chlamydia trachomatis Test using a Perkin-Elmer 9600 thermal cycler and a Bio-Tek EL800 plate reader.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Acceptance Criterion (Implied)Reported Device Performance
Precision/ReproducibilityCOBAS AMPLICOR Chlamydia trachomatis Test Precision Analysis (See Table 2 in source document):
  • Chlamydia trachomatis Spiked STM (IFU/PCR):
    • 0 IFU/PCR: Mean Absorbance 0.004, Total CV 117.6% (high due to very low mean value)
    • 1 IFU/PCR: Mean Absorbance 3.856, Total CV 3.7%
    • 10 IFU/PCR: Mean Absorbance 3.685, Total CV 5.9%
    • 50 IFU/PCR: Mean Absorbance 3.639, Total CV 5.4%
  • Kit Controls:
    • Negative: Mean Absorbance 0.004, Total CV 97.0% (high due to very low mean value)
    • Positive: Mean Absorbance 3.831, Total CV 7.0%
      Interpretation: Shows good reproducibility for positive samples across different operators and days, while very low absorbance negative samples show higher CV due to proximity to zero. |
      | Clinical Performance | Comparative Clinical Performance vs. Predicate Device (AMPLICOR MWP) (See Table 3 in source document):
  • Cervical Specimens (266 total):
    • COBAS AMPLICOR Pos & AMPLICOR MWP Pos: 34
    • COBAS AMPLICOR Pos & AMPLICOR MWP Neg: 1
    • COBAS AMPLICOR Neg & AMPLICOR MWP Pos: 1
    • COBAS AMPLICOR Neg & AMPLICOR MWP Neg: 230
  • Male Urethral Specimens (93 total):
    • COBAS AMPLICOR Pos & AMPLICOR MWP Pos: 16
    • COBAS AMPLICOR Pos & AMPLICOR MWP Neg: 1
    • COBAS AMPLICOR Neg & AMPLICOR MWP Pos: 0
    • COBAS AMPLICOR Neg & AMPLICOR MWP Neg: 76
  • Male Urine Specimens (280 total):
    • COBAS AMPLICOR Pos & AMPLICOR MWP Pos: 63
    • COBAS AMPLICOR Pos & AMPLICOR MWP Neg: 4
    • COBAS AMPLICOR Neg & AMPLICOR MWP Pos: 5
    • COBAS AMPLICOR Neg & AMPLICOR MWP Neg: 208
      Statistical analysis (McNemar's Test) found P > 0.4 for each specimen type, providing strong evidence of no significant difference in positive and negative results between the two test procedures. |
      | Substantial Equivalence | The document concludes that the COBAS AMPLICOR Analyzer (with the COBAS AMPLICOR Chlamydia trachomatis Test) provides substantially equivalent analytical and clinical performance to the predicate device. This is based on the precision data and the non-inferiority demonstrated in the clinical comparison. |

Study Details

  1. Sample Size used for the Test Set and the Data Provenance:

    • Precision Study (Non-Clinical):
      • Sample Size: 27 replicates for each of the 6 sample types (0, 1, 10, 50 IFU/PCR spiked samples, negative kit control, positive kit control). Total of 162 tests.
      • Data Provenance: Not explicitly stated, but likely laboratory-generated and prospective (performed specifically for the study).
    • Clinical Performance Study:
      • Sample Size: 639 clinical specimens.
        • 266 endocervical swabs
        • 93 male urethral swabs
        • 280 male urine specimens
      • Data Provenance: Not explicitly stated, but implies clinical samples (from patients). It's specified as "The clinical data reported here were obtained using the AMPLICOR Chlamydia trachomatis Test" implying retrospective use of existing clinical data, or prospective collection of samples that were then tested by both methods. Given the direct comparison side-by-side, it's more likely a prospective collection but doesn't explicitly state "prospective."

  2. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Precision Study: No external "ground truth" experts were used. Ground truth was defined by the spiked concentrations of C. trachomatis IFU/PCR in the samples and the kit controls.
    • Clinical Performance Study: The "ground truth" was established by the AMPLICOR microwell assay (predicate device), which served as the comparator. No specific number or qualifications of experts for reading "ground truth" are mentioned, as the comparison was between two assays. However, it's noted that "Two samples were culture positive/MOMP positive; three samples were culture negative/MOMP positive" in the footnotes of Table 3. This indicates that independent methods (culture, MOMP) were used as additional references for discordant results, but not as the primary ground truth for the overall comparison.

  3. Adjudication method for the test set:

    • No explicit adjudication method (like 2+1 or 3+1) is mentioned, as the studies did not involve subjective human reader interpretation of images or complex data needing consensus. The studies compared quantitative measurements (absorbance) and qualitative results (positive/negative) from an automated system with a predicate device.
    • For the discordant results in the clinical comparison (e.g., COBAS AMPLICOR Pos/AMPLICOR MWP Neg), the footnote suggests culture and MOMP positivity were used for reference, but it doesn't describe a formal adjudication process.

  4. 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, an MRMC comparative effectiveness study was not done. This device (COBAS AMPLICOR Analyzer) is an automated in vitro diagnostic (IVD) instrument, not an AI-powered image analysis tool or decision support system intended to assist human readers. Its purpose is to perform laboratory tests automatically, replacing manual laboratory procedures. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Yes, the studies focused on standalone performance. The COBAS AMPLICOR Analyzer is itself a standalone automated system.
      • The precision study evaluated the intrinsic reproducibility of the automated system.
      • The clinical performance study evaluated the output (qualitative result) of the COBAS AMPLICOR system against the output of a manually-performed predicate test. Both are "algorithm only" in the sense that they produce a result based on a defined protocol, though the COBAS AMPLICOR automates more steps.

  6. The type of ground truth used:

    • Precision Study: Defined concentrations of C. trachomatis (IFU/PCR) spiked into transport medium, and certified kit controls.
    • Clinical Performance Study: The predicate device (AMPLICOR microwell assay) was used as the comparator, effectively serving as the "ground truth" for the comparison of substantial equivalence. For specific discordant cases, culture positivity and MOMP (Major Outer Membrane Protein) positivity were used as additional, higher-tier references.

  7. The sample size for the training set:

    • Not applicable/Not mentioned. The COBAS AMPLICOR Analyzer is an automated instrument performing a defined chemical/molecular assay, not a machine learning or AI model that requires a "training set" in the conventional sense of algorithm development. The development of the instrument itself would involve engineering validation, but not a data-based "training set" like an AI product.

  8. How the ground truth for the training set was established:

    • Not applicable, as there was no "training set" for an AI or machine learning model.

§ 862.2170 Micro chemistry analyzer for clinical use.

(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.