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The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassy for the qualitative detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus, Strep A) antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection.

All negative test results should be confirmed by bacterial culture because negative results do not prection with Group A Streptococcus and should not be used as the sole basis for treatment.

Healgen Strep A Rapid Test Strip (Throat Swab) is a qualitative, lateral flow immunoassay for the detection of Strep A antigen directly from a throat swab sample.

In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's a breakdown of the acceptance criteria and study details for the Healgen Strep A Rapid Test Strip (Throat Swab):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • Clinical Study: 368 subjects (206 culture-positive, 162 culture-negative).
  • Analytical Precision: 180 determinations per sample type (60 determinations per site across 3 sites).
  • Analytical LoD: 21 results per dilution (7 operators x 3 lots).
  • Analytical Interference: Multiple tests across 3 lots for each interfering substance, for both positive and negative specimens.
  • Analytical Specificity (Cross-reactivity): Multiple tests across 3 lots for each organism by 3 professional users.
• Data Provenance:
  • The document does not explicitly state the country of origin for the clinical data.
  • The clinical study appears to be prospective/concurrent as it describes testing "subjects...exhibiting symptoms of pharyngitis by both the Healgen Strep A Rapid Test Strip (Throat Swab) and the culture studies." This implies collection of samples and testing using both methods at the time of study.
  • The analytical studies (precision, LoD, interference, specificity) were laboratory-based, performed internally or by designated personnel.

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

• Clinical Study Ground Truth: The ground truth for the clinical study was established by bacterial culture. The document implies that the culture results were considered the reference standard. It does not explicitly state the number of experts or their qualifications involved in performing or interpreting these cultures. However, bacterial culture is a standard clinical laboratory method typically performed by trained medical technologists or microbiologists.
• Analytical Studies:
  • Precision/Reproducibility: 6 professional operators (2 at each of 3 sites) participated. Their specific qualifications are not detailed beyond "professional operators."
  • LoD: 7 operators performed the testing. Their specific qualifications are not detailed beyond "operators."
  • Interference: 3 laboratory assistants with relevant experience performed the test.
  • Analytical Specificity: 3 professional users performed the test.

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

• The document does not describe an adjudication method (like 2+1 or 3+1) for establishing the ground truth in the clinical study. The reference standard (bacterial culture) appears to have been used directly.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done in the context of AI assistance. This device is a manual rapid diagnostic test strip, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here. The "operators" or "users" in the analytical studies are performing the manual test according to instructions.

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

• This question is not applicable as the device is a manual rapid test strip, not an algorithm or AI-driven system. It does not operate without human interaction.

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

• The ground truth for the clinical study was bacterial culture, which is considered the gold standard for diagnosing Group A Streptococcus bacterial infection.
• For the analytical studies (LoD, interference, specificity), the ground truth was based on known concentrations of target analytes (S. pyogenes) or known presence/absence of interfering/cross-reacting organisms.

8. The sample size for the training set

• The document does not mention a training set in the context of machine learning or AI. This is a traditional rapid diagnostic test, not a learning algorithm. The "training" of the device refers to its manufacturing and validation process, not data-driven machine learning.

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

• This question is not applicable as there is no mention or indication of a "training set" for an AI or machine learning model in this submission.

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Healgen COC One Step Cocaine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen MOP One Step Morphine Test is an immunochromatographic assay for the qualitative determination of morphine in human urine at a Cut-Off concentration of 300 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GO/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test are immunochromatographic assays for Cocaine and Morphine. Each assay test is a lateral flow, one step system for the qualitative detection of Benzoylecgonine and Morphine (target analyte) in human urine. The product is a single-use in vitro diagnostic device, which comes in the form of: Strips, Cassettes, DipCards, or Cups. It contains a Test Device (in one of the four formats), a package insert and a urine cup. Each test device is sealed with a desiccant in an aluminum pouch.

The sponsor, HEALGEN SCIENTIFIC LLC, submitted a 510(k) premarket notification (K141647) for the Healgen COC One Step Cocaine Test and Healgen MOP One Step Morphine Test. Both devices are immunochromatographic assays intended for the qualitative determination of Benzoylecgonine and Morphine, respectively, in human urine at a cut-off concentration of 300 ng/mL. They are available in Strip, Cassette, Dip Card, and Cup formats for in vitro diagnostic use, intended for both over-the-counter and prescription use. The predicate device is the K052115 First Check Multi Drug Cup 12.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity or specificity percentages to be achieved). However, the performance characteristics studies (precision, cut-off, interference, specificity, and method comparison) are presented to demonstrate the device's acceptable performance and substantial equivalence to the predicate. The "acceptance criteria" can be inferred from the positive results observed in these studies, particularly the concordance with GC/MS and the high percentage of correct results from lay users around the cut-off.

Healgen COC One Step Cocaine Test Performance (Summary from provided data):

Healgen MOP One Step Morphine Test Performance (Summary from provided data):

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

• Precision Study Test Set: For each drug (Cocaine and Morphine) and each format, 3 lots were tested. For each lot, 9 concentration levels were tested. For each concentration, tests were performed two runs per day for 25 days.

  • This implies 3 lots * 9 concentrations * (2 runs/day * 25 days/run) = 3 * 9 * 50 = 1350 tests per lot per concentration type (e.g., Cocaine Strip).
  • The results are reported as "X-/Y+" (Negative/Positive) out of 50 total readings per lot, meaning 50 tests were performed per lot per concentration level. So, 3 lots * 9 concentrations * 50 tests/concentration = 1350 tests were conducted for each device format (Strip, Cassette, Dip Card, Cup) for both Cocaine and Morphine.
  • Data Provenance: The samples were "prepared by spiking drug in negative samples." The document does not specify the country of origin, but it implies a controlled laboratory setting (in-house) rather than collected human samples for this specific study. It is retrospective in the sense that the concentrations were known and confirmed by GC/MS beforehand.

• Cut-off Verification Test Set: A total of 150 samples (equally distributed at -50%, -25%, cut-off, +25%, +50% cut-off concentrations) were tested. These were tested using three different lots of each device by three different operators.

  • Data Provenance: Samples were "spiking drug in negative samples." No country of origin is mentioned, likely in-house.

• Interference and Specificity Test Set: No specific sample size is given beyond "three batches of each device for all formats." The concentrations of interfering substances or cross-reactants were tested against drug-free urine and urine spiked at 25% above cut-off levels.

  • Data Provenance: Not specified, likely in-house laboratory.

• Method Comparison Studies (Clinical Samples Test Set): 80 unaltered clinical samples were used for each target drug (Cocaine and Morphine) and each device format (Strip, Cassette, Dip Card, Cup). Specifically, these were 40 negative and 40 positive samples.

  • Data Provenance: "unaltered clinical samples". Country of origin is not specified, but the study was performed "in-house." These were retrospective/archived samples as their GC/MS results were already known and they were blind-labeled.

• Lay-User Study Test Set: 140 lay persons tested the cocaine devices, and another 140 lay persons tested the morphine devices. Each participant was provided with 1 blind-labeled sample. For each drug, urine samples were prepared at 7 concentration levels (negative, +/-75%, +/-50%, +/-25% of the cutoff). The tables show 20 samples per concentration level, totaling 7 * 20 = 140 samples per drug group which corresponds to the number of lay users.

  • Data Provenance: Urine samples were prepared by "spiking drugs into drug free-pooled urine specimens." Country of origin is not specified. The study involved human participants, making it a prospective study in terms of user interaction, but the samples themselves were prepared in a controlled manner.

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

• Precision, Cut-off, Interference, Specificity, Lay-User Studies: The ground truth for these studies was established by GC/MS confirmation of the spiked drug concentrations in the urine samples. GC/MS (Gas Chromatography/Mass Spectrometry) is a highly accurate and accepted method for drug confirmation. No human experts are explicitly mentioned for establishing ground truth as GC/MS is the gold standard.
• Method Comparison Studies (Clinical Samples): The ground truth was established by GC/MS results. The study states: "compared to GC/MS results." Again, no human experts are explicitly mentioned for interpreting these GC/MS results as they are quantitative and serve as the definitive ground truth for drug concentration.

4. Adjudication Method for the Test Set:

• Precision, Cut-off, Interference, Specificity Studies: No explicit adjudication method is mentioned beyond the initial GC/MS confirmation of sample concentrations. The device results were presumably compared directly to these known concentrations.
• Method Comparison Studies (Clinical Samples): Three "laboratory assistants" (referred to as Viewer A, Viewer B, Viewer C) independently interpreted the results of the rapid tests. The discordant results (where the rapid test device result did not match the GC/MS ground truth) are listed individually for each viewer and sample. This indicates that while there were multiple readers (viewers), their results were not adjudicated against each other to form a consensus before comparison to GC/MS. Instead, individual performance against GC/MS was reported.
• Lay-User Study: Results from individual lay persons were compared against the GC/MS confirmed concentrations of the samples they tested. No adjudication between lay readers is mentioned; each reader's accuracy was assessed independently.

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 immunochromatographic assay for drug detection in urine, which is a rapid, visually-read test. It does not utilize AI. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed and is not applicable to this type of device. The studies involved human readers (laboratory assistants and lay users) interpreting the results of a non-AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a manual, visually-read immunochromatographic test. There is no algorithm component to perform standalone testing. The performance characteristics represent the device's inherent analytical capabilities when used as intended.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The primary ground truth used for all performance studies (precision, cut-off, interference, specificity, and method comparison) was GC/MS (Gas Chromatography/Mass Spectrometry). This is considered a highly accurate and quantitative analytical method, serving as an objective gold standard for drug concentration in urine. For the lay-user study, the ground truth was also GC/MS confirmed drug concentrations in the prepared samples.

8. The Sample Size for the Training Set:

This is a rapid diagnostic test, not a machine learning or AI-based device, so the concept of a "training set" in the context of algorithm development is not applicable. The device's formulation and manufacturing processes are likely developed through R&D and optimization, not through training on a dataset in the AI sense.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable.

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Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

The provided document describes the performance characteristics of the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test, and concludes that they are substantially equivalent to a predicate device.

Here's an analysis of the acceptance criteria and the studies that support it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by the results of the performance studies presented, primarily focused on their ability to correctly identify drug presence/absence at and around the specified cutoff concentrations. The studies demonstrate that for samples at or above +25% of the cutoff, the devices consistently show positive results, and for samples at or below -25% of the cutoff, they consistently show negative results. At the cutoff concentration, there is some variability, which is expected for qualitative tests.

Healgen THC One Step Marijuana Test (Cut-off: 50 ng/mL)

Healgen mAMP One Step Methamphetamine Test (Cut-off: 1000 ng/mL)

2. Sample Sizes and Data Provenance

• Precision Study: For each drug (THC and MET) and each format (Strip, Cassette, Cup, Dip Card), 8 concentrations (-100% cut off to +100% cut off) were tested. For each concentration, tests were performed two runs per day for 25 days. This implies 50 individual tests per concentration per lot, and 3 lots were used for each format.
  • Example for THC Strip: 8 concentrations x 50 tests/concentration x 3 lots = 1200 tests.
  • Data Provenance: The document does not explicitly state the country of origin but implies an in-house laboratory setting (referred to as "in-house" for comparison studies, and "prepared by spiking drug in negative samples" for precision, cut-off, and interference studies). The data is retrospective in the sense that samples were prepared and then tested. The urine samples were "negative samples" (for spiking) or "drug-free urine" (for interference), suggesting they were sourced specifically for testing purposes.
• Cut-off Verification Study: 150 samples were used, equally distributed at concentrations of -50%, -25%, Cut-Off, +25%, +50% Cut-Off. So, 30 samples per concentration.
  • Data Provenance: Similar to precision, prepared by spiking.
• Interference Study: Urine samples (drug-free and spiked with target drugs +/-25% Cut-Off) were used for testing various interfering substances. The number of samples per substance is not specified, but it was tested using three batches of each device for all formats.
  • Data Provenance: Assumed to be artificially created/spiked samples.
• Method Comparison Study: For each drug and each format, 80 unaltered clinical urine samples were used (40 negative, 40 positive).
  • Data Provenance: The samples are described as "clinical samples," suggesting real-world patient samples. The country of origin is not specified, but the study was performed "in-house." This is retrospective data.
• Lay-user Study: 140 lay persons participated. Urine samples were prepared at 7 different concentrations (negative, +/-75%, +/-50%, +25% of cutoff). For each concentration, 20 samples were prepared.
  • Data Provenance: Artificially prepared by spiking into drug-free pooled urine specimens.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH:
  • The ground truth for these analytical performance studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted gold standard method for quantifying drug concentrations in urine.
  • The document states that "Each drug concentration was confirmed by GC/MS" and that the "concentrations of the samples were confirmed by GC/MS." No human experts are explicitly mentioned for establishing ground truth from GC/MS results, as GC/MS is an objective analytical method.
• Method Comparison Study:
  • The ground truth for the 80 clinical samples was established by GC/MS results.
  • No specific number or qualifications of human experts are mentioned for interpreting the GC/MS results or establishing the ground truth from them.
• Lay-user Study:
  • Ground truth was established by GC/MS for the spiked urine samples.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and pH: For these analytical studies, GC/MS was the objective reference. The testing was done by unspecified personnel; "sample aliquots were blinded labeled by the person who prepared the samples and won't take part in the sample testing" (precision study). This suggests a blinding mechanism but no explicit multi-reader adjudication process for the actual device results.
• Method Comparison Study: Three laboratory assistants were the "operators" who ran the devices and presumably interpreted the results. The comparison was against GC/MS. The individual results of each viewer are reported, and then discordant results are listed. There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus among the three viewers) to arrive at a single device result per sample if their interpretations differed. Each viewer's interpretation is compared independently to the GC/MS ground truth.
• Lay-user Study: The study involved "140 lay persons" each testing "1 blind labeled sample and a device." The "Lay person results" table shows aggregate counts of positive/negative results. It does not describe an adjudication process for discordant interpretations among lay users on a single sample, as each lay user tested a unique sample (or set of samples for the overall study) and their individual interpretation was the data point.

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

No MRMC comparative effectiveness study was described. The studies focused on the performance of the device itself, observed by laboratory assistants (method comparison) or lay users (lay-user study), against an objective ground truth (GC/MS). There is no comparison of "human readers improve with AI vs without AI assistance" because the device is a simple, qualitative immunochromatographic assay, not an AI-powered diagnostic system requiring human interpretation of complex AI outputs.

6. Standalone Performance Study (Algorithm Only)

The device itself is a standalone, qualitative diagnostic test (immunochromatographic assay). All the performance studies (precision, cut-off, interference, specificity, method comparison, lay-user study) assess the standalone performance of the device without human interpretation being the primary variable. The "human-in-the-loop" component is essentially the reading and interpretation of the colored lines on the test strip as positive or negative, which is intrinsic to this type of device. There isn't an "algorithm" in the sense of a sophisticated computational model that could be evaluated separately from the physical test.

7. Type of Ground Truth Used

The primary and consistently used ground truth for all analytical and comparative studies was GC/MS (Gas Chromatography/Mass Spectrometry). This is an objective, highly accurate analytical method for drug concentration determination.

8. Sample Size for the Training Set

The document does not describe the development of an "algorithm" or "AI" system that would typically require a training set. This is an immunochromatographic assay, which relies on chemical and biological reactions rather than machine learning algorithms. Therefore, there is no "training set" in the context of AI. The product validation data described (precision, cut-off, interference, specificity, method comparison) serves to demonstrate the device's performance, not to "train" it.

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

As there is no "training set" in the context of AI/algorithm development for this device, this question is not applicable. The device's inherent design and manufacturing processes are validated by the performance studies using GC/MS as the ground truth.

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The Healgen hCG One Step Pregnancy Test Strip is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

The Healgen hCG One Step Pregnancy Test Cassette is an in vitro diagnostic visual qualitative immunochromatographic assay designed for the rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. Urine sample collected with cup only. For Over-The-Counter self-testing use.

Not Found

The provided document is an FDA 510(k) clearance letter for the Healgen hCG One Step Pregnancy Test Strip and Cassette. It confirms substantial equivalence to a predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the actual 510(k) submission or a scientific publication.

Therefore, I cannot fully answer your request with the input provided. However, I can infer some aspects based on common FDA requirements for such devices.

Here's what can and cannot be answered based on the provided text:

What can be extracted:

• Device Name: Healgen hCG One Step Pregnancy Test Strip, Healgen hCG One Step Pregnancy Test Cassette
• Indications for Use: Rapid determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy, for Over-The-Counter self-testing use.
• Type of Test: In vitro diagnostic visual qualitative immunochromatographic assay.

What cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter. It would be in the detailed device performance section of the 510(k) submission. Acceptance criteria for pregnancy tests typically include sensitivity (limit of detection, analytical sensitivity), accuracy (agreement with a reference method), and sometimes precision.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. For an OTC pregnancy test, ground truth is usually based on a quantitative lab reference method for hCG.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Highly unlikely for a qualitative, visually read OTC pregnancy test. This type of study is more common for imaging devices or algorithms that interpret complex data. The performance would be assessed against a quantitative standard, not typically human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a visual qualitative assay, meaning a human reads the result directly. It's not an algorithm.
7. The type of ground truth used: For a pregnancy test, the ground truth for hCG detection is typically established by a quantitative laboratory method (e.g., quantitative serum or urine hCG assay) to determine the precise hCG concentration.
8. The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" or "AI" that requires a training set in the conventional sense for a visual immunochromatographic assay.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

To obtain this detailed information, one would need to review the actual 510(k) submission (if it's publicly available and unredacted) or scientific publications related to the device's validation.

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The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

Healgen Series Reagent strips for Urinalysis and urine analyzers are in vitro diagnostic test devices that use reagents for qualitative and semiquantitative urinalysis.

The device is composed of several color pads aligned on a strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.

Healgen Series Reagent Strip provides tests for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Ascorbic Acid and Leukocytes in Urine.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the Healgen Series Reagent Strips and Analyzers for Urinalysis:

Overview:
The submission (K111999) describes the Healgen Series Reagent Strips and Analyzers, in-vitro diagnostic devices for qualitative and semi-quantitative urinalysis of various analytes. The primary goal of the submission appears to be demonstrating substantial equivalence to a predicate device (URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer). The information provided largely focuses on the analytical performance of the device rather than a clinical outcome study.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes analytical performance characteristics but does not explicitly state acceptance criteria for a "device meets acceptance criteria" study in the typical sense of a clinical trial with predefined end-points for sensitivity/specificity. Instead, it demonstrates the analytical capabilities and equivalence to a predicate device.

The tables below summarize the reported analytical performance related to:

• Analytical Limits (Cutoff): These are the thresholds at which a positive or negative result is typically determined.
• Reportable Ranges: These define the concentration ranges within which the device can provide meaningful qualitative or semi-quantitative results.
• Analytical Specificity (Interference Study): This identifies substances and their concentrations that do not affect the test results.

Table 1: Analytical Limits (Cutoffs)

Table 2: Reportable Ranges

Table 3: Analytical Specificity - Non-Interfering Concentrations of Substances

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

• Sample Size for Precision (repeatability/reproducibility):
  • Within-run: 20 replicates for each of 3 urine control levels, using strips from 3 lots.
  • Within-day: 3 urine control levels analyzed in duplicate, once a day, for 10 days, using strips from 3 lots.
  • Analytical Specificity: 5 test strips from each of 3 lots for each interference test.
• Sample Size for Clinical Comparison Studies: Not explicitly stated with a specific number of clinical specimens. The text only mentions "clinical comparison studies were conducted in 3 sites using the Healgen 11 Reagent Strip for Urinalysis and the predicate devices."
• Data Provenance: Not explicitly stated (e.g., country of origin). The document implies the studies were conducted to support a submission to the US FDA, but does not specify the geographic location of the clinical sites or specimen collection. The study appears to be prospective for the analytical performance evaluations (precision, specificity) as these were performed as part of the validation. The "clinical comparison studies" also imply prospective data collection for comparison purposes.

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

• Experts: The precision study involved "6 technicians" across 3 clinical sites. No specific qualifications (e.g., years of experience, specific certifications) are provided for these technicians, nor are they explicitly stated as "experts establishing ground truth."
• Ground Truth Qualification: For the precision and analytical specificity studies, the ground truth was established by using urine controls (Bio-Rad Level 1 and Level 2) and a 3rd control with analyte concentrations around cutoff, which was created by pooling Bio-Rad controls and spiking with pure analytes. For the clinical comparison study, the "ground truth" was implicitly the result obtained by the predicate device, as the study aimed to show comparability. There is no mention of external expert consensus or a gold standard method separate from the predicate for establishing ground truth for the clinical specimens.

4. Adjudication Method for the Test Set

• No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The analytical studies used technical replication (e.g., 20 replicates, duplicates over 10 days). For the clinical comparison, the comparison was made against the predicate device, suggesting the predicate's results served as the reference for comparability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

• No, an MRMC comparative effectiveness study was not explicitly described in the provided text in the typical sense of measuring human reader improvement with AI assistance.
• The document mentions "visual reading" alongside "instrumental reading" for the Healgen strips and states that "comparable testing data could be obtained by intended users when using the Healgen 11 Reagent Strip for Urinalysis and the legally marketed URISTK H Series Reagent Strips for Urinalysis from Dirui." This indicates a comparison between visual and instrumental readings, and between the new device and the predicate. However, it does not detail a study specifically designed to assess human reader improvement with AI (in this case, the analyzer acting as an 'AI' for reading strips) versus without it.
• The effect size of how much human readers improve with AI vs without AI assistance is not provided or discussed. The focus is on the performance comparability of the device (both visual and instrumental readings) to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a form of standalone performance was implicitly studied for the instrumental reading. The Healgen 500 and 800 Urine Analyzers use "reflectance photometry to quantitate analyte values" and provide "instrumental reading." Precision, analytical limits, and reportable ranges are characteristics of the instrument's performance (the "algorithm") when reading the strips. The "analytical specificity" study also evaluates the instrument's performance in the presence of interfering substances. While not strictly an "AI algorithm" in the modern interpretative sense, the analyzers are automated systems that perform the reading without human interpretation beyond initiating the test and reading the display.

7. The Type of Ground Truth Used

• For analytical performance (precision, reportable ranges, analytical specificity): The ground truth was based on controlled lab-prepared samples using Bio-Rad urinalysis controls and custom-spiked controls with known analyte concentrations.
• For clinical comparison studies: The ground truth was the results obtained from the predicate device (URISTK H Series Reagent Strips for Urinalysis and Dirui H-50, H-100, or H-500 Urine Analyzer).

8. The Sample Size for the Training Set

• The document does not explicitly mention a separate "training set" for an AI or machine learning model. This is consistent with the nature of reflectance photometry-based devices, which typically rely on calibrated physics-based models rather than data-driven machine learning for their primary function of quantifying color changes. The development of the reagents and the instrumental reading parameters would be based on chemical principles and extensive analytical validation rather than a distinct machine learning training set.

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

• As a distinct "training set" for AI/ML is not described, the concept of establishing ground truth for it is not applicable in the context of this submission. The device's operational parameters and measurement accuracy are established through the analytical performance studies rather than a machine learning training process.

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