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510(k) Data Aggregation
(165 days)
HOMOCYSTEINE TEST
The Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The Homocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Assay: The Homocysteine Enzymatic Assay is based on an enzyme cycling assay principle that assesses the co-substrate conversion product. In this assay, oxidized homocysteine (Hcy) is first reduced to free Hcy which then reacts with a co-substrate, S-adenosylmethionine, to form methionine and S-adenosylhomocysteine (SAH), catalyzed by a Hcy S-methyltransferase. SAH is assessed by coupled enzyme reactions where SAH is hydrolyzed into adenosine (Ado) and Hcy by SAH hydrolase, and Hcy is cycled into the Hcy conversion reaction to form a reaction cycle that amplifies the detection signal. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversions of NADH to NAD*. The concentration of Hcy in the sample is indirectly proportional to the amount of NADH converted to NAD which is measured spectrophotometrically at 340 nm.
Calibrator: The Homocysteine Calibrator Kit is a liquid, ready-for-use calibrator based on human serum. It is a single level calibrator with lot specific values and diluted on board the analyzer to create a 5-point calibration curve.
Control: The Homocysteine Control Kit consists of two ready-for-use controls based on human serum. The adjusted concentrations of the control components are in the low range for Control 1 and in the elevated range for Control 2.
This response summarizes the provided 510(k) Summary for the Homocysteine Enzymatic Assay, Calibrator Kit, and Control Kit. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing a specific study to prove the device meets acceptance criteria. Therefore, some requested information, particularly regarding ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is not present in the provided text.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) Summary presents a comparison of the draft device's features, including performance characteristics, against a predicate device. This comparison implicitly serves as a form of acceptance criteria, where the new device's performance is deemed acceptable if it is substantially equivalent to the cleared predicate.
| Feature / Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (Draft Device) |
|---|---|
| Intended Use | In vitro test for quantitative determination of L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. Assists in diagnosis of hyperhomocysteinemia or homocystinuria. |
| Sample Types | Serum, Lithium Heparin, K2EDTA, and K3EDTA |
| Instrument Platform | cobas c 501 |
| Calibrator | Homocysteine Calibrator; single level, diluted to form a 5-point calibration |
| Calibration Frequency | Every 7 days, after reagent lot change, and as required following quality control procedures |
| Calibration Mode | RCM |
| Controls | Homocysteine Controls |
| Reagent Active Ingredients | R1: S-adenosylmethionine, TCEP, 2-oxoglutarate, NADH; R2: homocysteine S-methyltransferase, glutamate dehydrogenase, casein (bovine); R3: adenosine deaminase (bovine), S-adenosyl-homocysteine hydrolase, casein (bovine) |
| Reagent Stability (Unopened) | 2-8 °C until expiration date |
| Reagent Stability (On-board in use) | 4 weeks |
| Measuring Range | 3 – 50 µmol/L |
| Lower Limits of Measure | LoB = 3 µmol/L; LoD = 3 µmol/L |
| Precision (CV) | Hcy Control 1: Mean 12.2 µmol/L, CV Repeatability 1.5%, CV Intermediate Precision 2.1% |
| Hcy Control 2: Mean 39.1 µmol/L, CV Repeatability 1.8%, CV Intermediate Precision 2.0% | |
| Human serum 1: Mean 8.26 µmol/L, CV Repeatability 2.0%, CV Intermediate Precision 2.3% | |
| Human serum 2: Mean 13.1 µmol/L, CV Repeatability 1.8%, CV Intermediate Precision 2.1% | |
| Human serum 3: Mean 30.0 µmol/L, CV Repeatability 1.4%, CV Intermediate Precision 1.8% | |
| Human serum 4: Mean 44.4 µmol/L, CV Repeatability 2.0%, CV Intermediate Precision 2.2% | |
| Expected Values | US: 15 µmol/L cut-off for normal in adults. Europe: 12 µmol/L cut-off for normal in adults. |
| Interferences | Methotrexate, carbamazepine, phenytoin, nitrous oxide, anticonvulsants, or 6-azuridine triacetate may cause higher Hcy levels. S-Adenosylhomocysteine (SAH) causes positive interference but is at sub-nmol/L in normal plasma. No significant interference from Icterus, Hemolysis (up to H index 100), Lipemia (up to L index 250), Triglycerides (up to 1790 mg/dl). No interference from common drug panels, Glutathione (0.5 mmol/L), Cystathionine (100 µmol/L), and Pyruvate (0.5 mmol/L). 3-deazaadenosine inhibits key enzymes. Gammopathy (IgM) may cause unreliable results. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for a "test set" in the context of a clinical validation study. The precision data provided refers to "Hcy Control 1," "Hcy Control 2," and "Human serum 1, 2, 3, 4." The number of samples for each of these categories is not specified.
The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided 510(k) summary. The document focuses on analytical performance characteristics rather than clinical diagnostic accuracy requiring ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
An MRMC study is typically associated with imaging devices or diagnostic tests where human interpretation is a critical component. This device is an in vitro diagnostic (IVD) assay for quantitative determination of a biomarker. Therefore, an MRMC comparative effectiveness study involving human readers would not be applicable or expected for this type of device, and no such study is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The provided data pertains to the analytical performance of the automated Homocysteine Enzymatic Assay on Roche/Hitachi cobas c systems. This inherently represents standalone (algorithm only/instrument only) performance, as it measures the assay's ability to precisely and accurately quantify Homocysteine in biological samples. The reported precision and interference studies demonstrate this standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the analytical performance studies (e.g., precision, measuring range, interference), the "ground truth" is established by:
- Known concentrations: For controls and calibrators, the concentrations are precisely manufactured and known.
- Reference methods or accepted analytical techniques: For validation of accuracy and linearity, comparison to established reference methods or highly accurate laboratory methods would typically be employed, although specific details are not provided in this summary.
- Spiked samples: Interference studies often involve spiking samples with known interferents to assess their effect.
There is no mention of expert consensus, pathology, or outcomes data as a ground truth for the performance claims presented in this analytical device summary.
8. The Sample Size for the Training Set
This information is not available in the provided 510(k) summary. The document describes an enzymatic assay, not an AI or machine learning algorithm that typically requires a distinct training set. The "training" in this context would likely refer to method development and optimization, for which specific sample sizes might not be explicitly documented in a 510(k) summary focused on substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
As noted above, this information is not available as the context for a "training set" in an AI/ML sense is not relevant here. For the development and optimization of the enzymatic assay, the "ground truth" would be established through a combination of chemical principles, known substrate/product concentrations, and potentially comparison with established methods during the R&D phase.
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(70 days)
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma.
The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc.
Not Found
The provided text describes an FDA 510(k) premarket notification for the Polymedco Homocysteine Test. However, it does not contain specific details about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study designs (e.g., MRMC, standalone).
Therefore, I cannot populate the table or answer the questions with the requested information based on the provided document. The document is primarily an FDA clearance letter and an "Indications for Use" statement, not a detailed study report.
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for establishing ground truth for the test set.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document only states the device's intended use and FDA clearance, implying that studies were conducted to support the substantial equivalence claim, but the details of those studies are not included in this particular set of pages.
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