FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system. The system is comprised of there main elements: The VITROS Immunodiagnostic Products range of immunoassay products in this case VITROS Immunodiagnostic Products Cortisol Reagent Pack, VITROS Immunodiagnostic Products Cortisol Calibrators (cleared under K983990) and VITROS Immunodiagnostic Products Metabolism Controls (cleared under K983990), which are combined by the VITROS Immunodiagnostic System to perform the VITROS Cortisol assay. The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919). Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the VITROS Immunodiagnostic Products Cortisol Assay. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the following information cannot be fully extracted or is not explicitly stated in the document:

A table of acceptance criteria and the reported device performance: The document only provides a comparison of device characteristics between the new and predicate devices (Table 1) and a general statement of "equivalent performance." It does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or detailed performance data against those criteria.
Sample sized used for the test set and the data provenance: The document states that "testing human samples throughout the assay range" was done, but does not provide specific sample sizes for test sets, data provenance (e.g., country of origin), or whether the study was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method for the test set: Not provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is an in vitro diagnostic device, not an image-based AI system that would involve human readers. Therefore, an MRMC study is not applicable or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an immunoassay system, not an algorithm in the context of AI. Its performance is inherent in its design and operation.
The type of ground truth used: The document mentions "manufactured reagents, positive and negative controls and testing human samples." For an immunoassay, the 'ground truth' would typically be established by reference methods or validated clinical diagnoses/outcomes, but this is not explicitly detailed.
The sample size for the training set: Not applicable in the context of an immunoassay for which no separate "training set" is described for an algorithm.
How the ground truth for the training set was established: Not applicable.

Here's what can be extracted based on the provided text, focusing on the comparison to the predicate device and the general statement of performance:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, precision, bias thresholds). Instead, "equivalent performance" to the predicate device is the overarching acceptance criterion for the 510(k) submission.

Device Characteristic	Predicate Device (K983990-Current)	New Device (Modified)	Note on Performance
Reportable Range	0 to 1700 nmol/L	4.39 to 1700 nmol/L	The new device has a slightly different lower limit for its reportable range, starting at 4.39 nmol/L compared to 0 nmol/L for the predicate. The document implies that performance within this modified range is equivalent.
Sample type	Serum, plasma (EDTA or heparin) or urine.	Serum plasma (EDTA or heparin) or urine.	No change. Performance is implied to be equivalent across these sample types.
Biotinylated Antibody Reagent	Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of two bleeds from a single sheep immunized in-house at Pollards Wood). Concentration: 1.5 mg/Kg	Sheep polyclonal anti-cortisol antibody biotinylated antibody reagent (pool of eight bleeds from two sheep immunized in-house at Pollards Wood). Concentration: 0.5 mg/Kg	Antibody source and concentration changed. The submission declares that "Equivalent performance was demonstrated using manufactured reagents... and testing human samples".
HRP Conjugate Reagent	Contains Bovine Alpha Globulin	Removed Bovine Alpha Globulin. Added ANS (8-anilino-1-napthalenesulfonic acid) to correct for azide.	Reagent composition changed. The submission declares that "Equivalent performance was demonstrated using manufactured reagents... and testing human samples".
Basic principle	Solid phase immunoassay	Solid phase immunoassay	No change.
Tracer	Enzyme labeled	Enzyme labeled	No change.
Instrumentation	VITROS Immunodiagnostic System	VITROS Immunodiagnostic System	No change.
Sample volume	25µL	25µL	No change.
Incubation time and temperature	30 minutes at 37°C	30 minutes at 37°C	No change.

Study Proving Acceptance Criteria:

The study described is a comparison study demonstrating substantial equivalence of the modified VITROS Immunodiagnostic Products Cortisol Assay to the previously cleared predicate device (K983990). The conclusion states: "Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples throughout the assay range."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The document only mentions "testing human samples throughout the assay range."
Data Provenance: Not specified (e.g., country of origin not mentioned).
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this is not an image-based diagnostic or expert interpretation study. The 'ground truth' for an immunoassay's performance would typically refer to the true concentration of cortisol in samples, usually determined by reference methods or clinical gold standards. The document does not detail how this ground truth was established for the "human samples."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of immunoassay study.

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. This is an in vitro diagnostic device, not an AI system.

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

The device itself is a standalone immunoassay system. The performance evaluated is the direct output of the system. There is no concept of an "algorithm only" in the context of human-in-the-loop for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implies that performance was assessed against "manufactured reagents, positive and negative controls and testing human samples." For human samples, the ground truth for cortisol levels would typically come from a well-established reference assay or a clinically validated method, but this is not explicitly detailed.

8. The sample size for the training set

Not applicable. This is an immunoassay, not a machine learning algorithm requiring a distinct "training set."

9. How the ground truth for the training set was established

Not applicable.

Summary

Regulation Number and Section

§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.

(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.