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The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of carbon dioxide test systems.
The Urine Chemistry Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of clinical chemistry test systems.
The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of clinical chemistry test systems.
The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration or
calibration verification of serum electrolyte test systems.
The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibration
or calibration verification of clinical chemistry test systems.
The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration or
calibration verification of clinical chemistry test systems.
The ISE Standard Kit is an in vitro diagnostic product intended for calibration or
calibration verification of clinical chemistry test systems.
The ISE Standard (S4) is an in vitro diagnostic product intended for calibration or
calibration verification of clinical chemistry test systems.
The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended for
calibration or calibration verification of clinical chemistry test systems :

All calibrator materials included in this submission are aqueous, primary standards containing known amounts of each component for in vitro diagnostic use. Standardization is achieved by gravimetric procedure. Verification is performed using available NIST Standard Reference materials.

The provided document is a 510(k) premarket notification for Verichem Laboratories Inc.'s diagnostic calibrators. It describes the properties and intended use of several calibrator kits, including Carbon Dioxide Standard Kit, Urine Chemistry Standard Kit, Urine Uric Acid Standard Kit, Electrolyte Standard Kit, Cholesterol Standard Kit, Uric Acid Standard Kit, ISE Standard Kit, ISE Standard (S4), and Multi-Chemistry Standard Kit.

This document is a regulatory submission for in vitro diagnostic calibrators, not for an AI/ML-based medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to this type of device.

Instead, the performance of these calibrators is based on analytical performance characteristics, primarily:

• Precision/Reproducibility: Stated as typically

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The Microprotein Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

MICROPROTEIN STANDARD KIT

This document is a 510(k) clearance letter from the FDA for a device called "Microprotein Standard Kit." It does not contain information about acceptance criteria, study details, or performance data for the device.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. The 510(k) process often relies on existing data or equivalence to established devices rather than requiring new clinical trials with detailed performance metrics and acceptance criteria as would be found in a Premarket Approval (PMA) application or a de novo submission.

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The MATRIX PLUS Multi-calibrator Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

MATRIX PLUS MULTI-CALIBRATOR KIT

The provided document is a 510(k) premarket notification letter from the FDA for a device called "MATRIX PLUS™ Multi-Calibrator Kit." This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the given text. The letter only confirms that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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The Ammonia/Iron Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Not Found

The provided document is a 510(k) clearance letter from the FDA for an "Iron Standard Kit" (later referred to as "Ammonia/Iron Standard Kit"). This type of document does not contain the detailed study information required to answer your questions about device performance, acceptance criteria, ground truth establishment, sample sizes, or expert qualifications.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the device was cleared based on its equivalence to a legally marketed predicate device, not necessarily on a full clinical trial demonstrating novel performance against defined acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is typically found in the 510(k) submission itself, not in the clearance letter.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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: This device is an "Iron Standard Kit," which is a calibration or reference material, not an AI-powered diagnostic or imaging device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present for performance assessment in the context you're asking. For a standard, its "ground truth" would relate to its certified concentration or purity, which would be established by analytical methods, not expert consensus or pathology on human specimens.
8. The sample size for the training set: Not relevant for a standard kit.
9. How the ground truth for the training set was established: Not relevant for a standard kit.

The letter's key information is that the device (Iron Standard Kit) is "intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens." Its clearance is based on substantial equivalence, implying it functions similarly to existing, cleared iron standard kits.

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