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510(k) Data Aggregation

    K Number
    K072640
    Device Name
    IRISPEC,CA/CB/CC
    Manufacturer
    IRIS DIAGNOSTICS
    Date Cleared
    2007-12-21

    (94 days)

    Product Code
    JJW
    Regulation Number
    862.1660
    Type
    Abbreviated
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K945913
    Why did this record match?
    Device Name :

    IRISPEC,CA/CB/CC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

    Device Description

    IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, bilirubin. No human sourced materials.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the IRISpec™ CA/CB/CC device, based on the provided 510(k) summary:

    1. Table of Acceptance Criteria and Reported Device Performance

    Device: IRISpec™ CA/CB/CC

    Acceptance Criteria CategoryAcceptance CriteriaReported Device Performance
    Ascorbic Acid Concentrate40 mg/dL (min) - Chosen to strongly saturate ascorbic acid pads on iChem 10 SG and vChem strips.All samples provided ascorbic acid values of 40 mg/dL.
    pH5.0 (reference) - Same as CB control.Not explicitly stated as a test result, but presumed met as it matches the CB control and is a reference value.
    Specific Gravity1.035 (reference) - Same as CB control.Not explicitly stated as a test result, but presumed met as it matches the CB control and is a reference value.
    Base MatrixIdentical to CB buffer - Chosen so that CB could be the negative for CC for ascorbic acid.Met; the description states the matrix for Part C is identical to Part B.
    Matrix EffectsNo measurement differences observed when comparing proposed CC control to human negative urine spiked with ascorbic acid at 40 mg/dL, tested in triplicate on iChem 100 Urine Chemistry Analyzer.No measurement differences were observed.
    Closed Vial StabilityNo more than one grade change in concentration over a six-month period when stored at 2-8°C, compared to reference samples stored at -20°C. For negative controls (CA/CB), remaining NEG for ascorbic acid.All vials tested had recoveries of 40 mg/dL ascorbic acid for all three lots after 7 months of real-time stability. All negative controls (CA and CB) tested NEG for ascorbic acid after 7 months of real-time stability.
    Accelerated Temperature Stability (25°C)Ascorbic acid values of 40 mg/dL during the entire study length (20 days, 16 days, 10 days, 3 days) at 25°C. Also, 40 mg/dL after 6 months at 25°C. For negative controls (CA/CB), remaining NEG for ascorbic acid after 6 months at 25°C.All samples provided ascorbic acid values of 40 mg/dL during the entire study at 25°C. All IRISpec™ CC samples provided ascorbic acid values of 40mg/dL after 6 months at 25°C. All IRISpec™CA and CB controls were NEG for ascorbic acid.
    Accelerated Temperature Stability (35°C)Ascorbic acid values of 40 mg/dL during the entire study length (7 days, 6 days, 3 days, 1 day) at 35°C.All samples provided ascorbic acid values of 40 mg/dL during the entire study at 35°C.

    2. Sample Size Used for the Test Set and Data Provenance

    • Test Set Sample Size:
      • Matrix Effects: 3 lots of proposed CC control.
      • Closed Vial Stability: 3 lots of proposed CC controls, plus IRISpec™CA and IRISpec™CB as negative controls.
      • Accelerated Temperature Stability: 3 lots of IRISpec™CC controls, plus IRISpec™CA and IRISpec™CB for the 6-month 25°C study.
    • Data Provenance: The data is generated internally by the manufacturer (Iris Diagnostics, a Division of IRIS International Inc). The country of origin is implicitly the USA, where the company is located. The studies are prospective in nature, as they involve testing the performance and stability of newly manufactured lots of the device over time and under various conditions.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

    This device is a quality control material, not a diagnostic imaging or interpretive device that requires expert human interpretation for ground truth. The "ground truth" for this type of device is established by its formulation and verified chemical properties. The expected values (e.g., 40 mg/dL ascorbic acid) are determined by the precise manufacturing and spiking process.

    Therefore, no external experts in the sense of clinicians or radiologists were used to establish ground truth for this device. The "expertise" involved would be the internal R&D and quality control personnel who formulated the control and verified its chemical composition.

    4. Adjudication Method for the Test Set

    Not applicable. As described above, the ground truth is established by the chemical formulation and direct analytical measurements, not by expert consensus or subjective interpretation requiring adjudication.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

    No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) and the AI's impact on their performance is being evaluated. This device is a quality control material and does not involve human readers interpreting diagnostic cases.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

    Yes, in a way, this entire submission represents a "standalone" performance study of the quality control material itself. The device (IRISpec™ CA/CB/CC) is designed to have specific chemical properties and stability. The studies evaluate whether the device itself (the "algorithm" in this context refers to the intrinsic properties of the QC material) consistently meets these specifications when tested by an analytical instrument (like the iChem 100 Urine Chemistry Analyzer). There is no "human-in-the-loop" performance being measured for the QC material directly, only its inherent performance as a standard.

    7. The Type of Ground Truth Used

    The ground truth used is based on chemical formulation and direct analytical measurement (laboratory analysis). The device is formulated to contain a specific concentration of ascorbic acid (40 mg/dL). Its performance is then verified by measuring this concentration using a standardized analytical instrument (iChem 100 Urine Chemistry Analyzer) and comparing it to the expected, formulated value. For negative controls, the ground truth is the absence of the analyte (NEG).

    8. The Sample Size for the Training Set

    Not applicable. This device is a chemical quality control material, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "knowledge" comes from its chemical formulation and manufacturing process, not from learning from a dataset.

    9. How the Ground Truth for the Training Set was Established

    Not applicable, as there is no training set for this type of device.

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