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The ImmunoDip™ Urinary Albumin Screen tests for the presence of elevated levels of albumin in urine. Elevated urinary albumin is also known as microalbuminuria. Elevated albumin is an early sign of possible kidney damage. Detection of elevated urinary albumin can aid in the early detection and monitoring of the course of incipient nephropathy in diabetics and hypertensive patients. For IN VITRO diagnostic use.

ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip which is encased in a plastic housing. The ImmunoDip™ Urinary Albumin Screen is placed into a urine sample for at least three minutes and is then removed and read. Results are determined by visually comparing the relative color intensity of two blue bands to obtain a semi-quantitative result of Negative (18 mg/L).

ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip containing monoclonal mouse antibodies against human serum albumin bound to colored latex beads. Human albumin is fixed in a band at the bottom half of the testing region. Goat anti-mouse antibodies are fixed in a band at the top half of the testing region. The dipstick is encased in an open-ended plastic housing.

When the dipstick is placed into a urine sample cup, the urine sample migrates up the test strip. Albumin present in the urine binds with blue colored latex beads present in the strip. Both beads and albumin are carried up the device by capillary action. At low levels of albumin, the great majority of blue beads are bound at the lower band containing human albumin. At higher levels of albumin, many of the beads pass through the lower band and are bound at the upper band. Levels of albumin above the decision level value of 18 mg/L will produce color on the upper band which is darker than the lower band. By observing the appearance of the two lines, the user can semi-quantitatively determine the urine microalbumin concentration as either Negative (18 mg/L).

The ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip intended to detect elevated levels of albumin in urine (microalbuminuria), which can indicate early kidney damage in high-risk patients.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Precision Study: The sample size for the "test set" in the precision study is not explicitly stated in terms of number of urine samples. It refers to "two levels of albumin in urine" and "all instances of within-day, between-day, within-run and between-run testing" with 100% agreement.
• POL Studies: "Six proficiency samples over a clinically relevant range of concentrations (4.5 mg/L, 9.0 mg/L, 15 mg/L, 22 mg/L, 36 mg/L and 72 mg/L)." The number of users (professional and POL users) and the number of replicates (15 replicates within-run, 5 different days between-runs, 3 POL sites between sites) contribute to the overall sample size but the exact number of unique "test set" samples is not provided.
• Clinical Studies: For comparison against predicate methods, "clinical urine samples" were used, but the specific number of these samples is not mentioned.
• Data Provenance: The document does not explicitly state the country of origin for the data. The submitter is based in Canada. The POL studies involved "Physician Office Laboratory (POL) studies" and "3 POL sites," implying real-world settings, but whether these were prospective or retrospective is not specified for all studies. The precision study was an "internal 20 day precision study."

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

• Precision Study: "two operators and two additional observers" were involved in determining agreement. Their qualifications are not specified beyond "operators" and "observers."
• POL Studies: "expected results" were used as the ground truth for the 6 proficiency samples. The method or expertise used to establish these "expected results" is not detailed.
• Clinical Studies: The "ground truth" was established by two predicate quantitative methods: the Beckman Array (K922273) and the Kamiya (Crestat) Microalbumin Assay (K934146), and one semi-quantitative method, the DCLare™ ImmunoDip™ Stick for Microalbuminuria (K972337).

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1).
• In the precision study, 100% agreement was obtained between "two operators and two additional observers," implying direct consensus or agreement without needing a tie-breaker.
• For the POL and clinical studies, the results were compared against an "expected result" or predicate device results, not against a human adjudicated consensus derived from multiple readers of the ImmunoDip device itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A formal MRMC comparative effectiveness study, as typically understood in the context of comparing human readers with and without AI assistance, was not conducted.
• The studies involved comparing the ImmunoDip device's performance by "POL users" versus "trained laboratory personnel" and against established "predicate methods." There is no mention of an "AI assistance" component or an effect size for human readers improving with AI.

6. Standalone (Algorithm Only) Performance

• The ImmunoDip™ Urinary Albumin Screen is a visual immunochromatographic test strip read by a human. Therefore, a standalone "algorithm only" performance study in the sense of a fully automated AI system without human interaction was not conducted, as the device itself is not a software algorithm. Its performance is the "standalone" performance based on visual interpretation.

7. Type of Ground Truth Used

• Precision Study: The ground truth was based on the consensus ("100% agreement") among two operators and two observers for known albumin levels (two levels specified).
• POL Studies: The ground truth for the proficiency samples was "expected results," which implies they were pre-determined values for the proficiency samples. The method of determination for these "expected results" is not specified but would typically come from a reference method or certified values.
• Clinical Studies: The ground truth was established by two full quantitative predicate methods (Beckman Array, Kamiya Microalbumin Assay) and one semi-quantitative predicate method (DCLare™ ImmunoDip™ Stick for Microalbuminuria).

8. Sample Size for the Training Set

• The document implies that the device is a test strip read visually by a human, not a machine learning or AI algorithm that requires a "training set" in the typical sense. Therefore, the concept of a "training set" as it relates to AI development is not applicable here. The studies described are for validation of the chemical-biological test strip and human interpretation.

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

• As the device is not an AI algorithm requiring a training set, this question is not applicable.

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The IGA Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic device intended to quantitatively measure immunoglobulin A in serum and plasma.

The IGA Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgA by its polyclonal antibodies.a

IgA from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 um. The increase in turbidity is proportional to the concentration of IgA and it is calculated from a five point calibration curve.

PEG IgA + Antibody ------------------------> IgA-Antibody Complex

a The antibody is manufactured by Dade Behring, Marburg, Germany

The provided text describes a 510(k) submission for the IGA Flex™ Reagent Cartridge, comparing it to a predicate device. Here's a breakdown of the acceptance criteria and study information:

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

Note: The document implies these criteria by presenting the results of the comparison study as evidence of substantial equivalence. Explicit acceptance criteria values (e.g., "correlation coefficient must be greater than 0.95") are not directly stated but are inferred from the conclusion of substantial equivalence based on these high values.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): 100 clinical patient samples
• Data Provenance: The samples are referred to as "clinical patient samples," suggesting they were collected from patients, but the country of origin is not specified. The study is retrospective, as it involves a "split sample comparison" where existing samples would have been analyzed by both devices. It is also prospective relative to the device submission date of 1999.

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

This information is not provided in the document. The "ground truth" for this type of device (quantitative measurement of a biomarker) is typically established by the predicate device's measurement, which is considered a reference standard rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpretation or consensus is required to establish ground truth or evaluate different interpretations, such as in image analysis or diagnostic assessments. For a quantitative immunoassay comparing a new device to a predicate, the comparison of numerical outputs doesn't involve adjudication in this sense.

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 is not applicable. The device is an automated in vitro diagnostic system, not an AI-assisted diagnostic tool that requires human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.

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

Yes, a standalone performance study was done. The "split sample comparison" between the IGA Flex™ reagent cartridge and the Beckman Immunoglobulin A assay represents a direct comparison of the performance of the new device (algorithm/system) against an established method, without human intervention in the measurement process itself.

7. The type of ground truth used

The "ground truth" for the performance evaluation was the measurements obtained from the predicate device, the Beckman Array® Immunoglobulin A Method. In this context, the predicate device acts as the reference standard against which the new device's measurements are compared.

8. The sample size for the training set

This information is not provided in the document. For a traditional immunoassay device like this, there isn't typically a "training set" in the machine learning sense. Any initial assay development or calibration would rely on characterized samples or standards, but those details are not part of this summary.

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

This information is not provided and is largely not applicable in the typical sense for this type of device. If developmental samples were used, their "ground truth" would likely be based on established laboratory methods or certified reference materials, but these details are beyond the scope of this 510(k) summary.

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The IGM Flex™ reagent cartridge for the Dimension® Clinical Chemistry System is an in vitro diagnostic test intended to quantitatively measure immunoglobulin M (IgM) in serum and plasma.

The IGM Flex™ reagent cartridge for the Dimension® clinical chemistry system is a quantitative, turbidimetric assay based on the precipitation of IgM by its polyclonal antibodies. IgM from serum or plasma reacts with its polyclonal antibodies to form an immunoprecipitate. Addition of polyethylene glycol accelerates the formation of the precipitate. Turbidity created by immunoprecipitation is measured as bichromatic endpoint measurements at 340 and 700 nm. The increase in turbidity is proportional to the concentration of IgM and it is calculated from a five point calibration curve.

Here's an analysis of the provided text, focusing on acceptance criteria and the study conducted for the IGM Flex™ Reagent Cartridge:

This submission is a 510(k) premarket notification for a medical device, which typically involves demonstrating substantial equivalence to a legally marketed predicate device rather than setting and proving specific acceptance criteria in the same way a novel device might establish clinical utility. For 510(k)s, the "acceptance criteria" are often implicitly tied to demonstrating comparable performance to the predicate.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device, the Beckman Array® Immunoglobulin M Method. This is primarily assessed through correlation between the new device and the predicate device.

Interpretation: The reported performance metrics (correlation coefficient, slope, and intercept) are presented as evidence that the IGM Flex™ Reagent Cartridge is "substantially equivalent in principle and performance" to the predicate, thus meeting the implicit acceptance criteria for a 510(k) clearance.

Study Details

The study described is a split sample comparison between the IGM Flex™ Reagent Cartridge and the predicate Beckman Immunoglobulin M Assay.

1. Sample size used for the test set and the data provenance:

   • Sample Size: 94 clinical patient samples.
   • Data Provenance: Not explicitly stated, but it refers to "clinical patient samples," suggesting human samples. The country of origin for the data is not specified, and neither is whether it was retrospective or prospective.

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

   • Not applicable / Not explicitly stated. For this type of in vitro diagnostic device (IVD) comparison, the "ground truth" for the test set is established by the predicate device's measurement. The study aims to correlate the new device's readings with the predicate's readings, rather than establishing a gold standard through expert consensus.

3. Adjudication method for the test set:

   • Not applicable. There was no human adjudication process involved in this direct comparison of quantitative measurements from two IVDs. The measurements from each device were compared statistically.

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. This was a comparison of two in vitro diagnostic assays, not an AI-assisted human reader study.

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

   • Yes, in essence. Both devices (the IGM Flex™ cartridge on the Dimension® system and the Beckman Array® IgM method) operate as standalone automated analytical systems. The study compared the direct output of these two systems. There is no "human-in-the-loop" component for interpretation described.

6. The type of ground truth used:

   • The "ground truth" in this comparative performance study is the measurements obtained from the legally marketed predicate device (Beckman Array® Immunoglobulin M Method). The new device's performance is gauged against this established method.

7. The sample size for the training set:

   • Not applicable / Not explicitly stated. This device is an IVD reagent cartridge, not a machine learning algorithm that requires a "training set" in the computational sense. The data presented is for performance validation, not for algorithm training.

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

   • Not applicable. As explained above, there isn't a "training set" for this type of device in the context of the provided information.

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