(116 days)
No
The description focuses on the enzymatic assay method and the performance characteristics of the test kit and analyzer, with no mention of AI or ML.
No.
This device is for in vitro diagnostic use, meaning it is used for diagnostic purposes, not for treating patients.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only." This directly indicates its role as a diagnostic device.
No
The device description explicitly states that the system consists of a "HCY POC Test Kit" containing reagents and a "HCY POC Test Control Kit," both of which are physical components. It also mentions the use of a "SMART analyzer," which is a hardware device. Therefore, this is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use only." It also describes the intended use as the "in vitro quantitative determination of total L-homocysteine in serum or plasma" to "assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria." This clearly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details a test kit containing reagents for the quantitative determination of Homocysteine in human serum or plasma, which are biological specimens. The method described is an enzymatic assay performed outside the body.
- Components: The system includes a "HCY POC Test Kit" with reagents and a "HCY POC Test Control Kit," both of which are typical components of IVD systems.
- Performance Studies: The document includes performance studies such as precision, linearity, interference, and comparison studies using human serum and plasma samples, which are standard evaluations for IVD devices.
- Predicate Device(s): The listed predicate devices are also IVD assays (Diazyme Homocysteine Assay and Diazyme Homocysteine 2 Reagent Enzymatic Assay Kit).
All these factors confirm that the Diazyme HCY POC Test Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Diazyme's HCY POC Test Kit is intended to be used with the SMART analyzer in a Point-of-Care setting for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only.
Product codes
LPS; Test, Homocysteine
Device Description
Diazyme HCY POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Homocysteine (HCY) in human serum or plasma. Diazyme HCY POC Test is based on a novel enzyme cycling method as published in the Journal of Clinical Chemistry. In this assay, oxidized HCY is first reduced to free HCY which then reacts with a co-substrate, S-adenosylmethionine (SAM) catalyzed by a HCY S-methyltransferase to form methionine (Met) and S-adenosylhomocysteine (SAH). SAH is assessed by coupled enzyme reactions including SAH hydrolase, adenosine (Ado) deaminase and glutamate dehydrogenase, wherein SAH is hydrolyzed into adenosine (Ado) and HCY by SAH hydrolase. The formed HCY that is originated from the co-substrate SAM is cycled into the HCY conversion reaction by HCY S-methyltransferase. This forms a co-substrate conversion product-based enzyme cycling reaction system with signification of detection signals. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversion of NADH to NAD+. The concentration of HCY in the sample is indirectly proportional to the amount of NADH converted to NAD+ (ΔA340mm).
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37℃ and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme HCY POC Test system thus consists of the following:
- HCY POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- HCY POC Test Control Kit. Controls are provided for quality control of the . HCY POC Test.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Point-of-Care setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Precision/Reproducibility:
- Precision study at manufacture site: Three serum controls (7.3, 11.87, and 29.32 umol/L HCY) were tested in duplicate, two runs per day, over ten working days using two different lots of reagents on three different SMART Analyzers.
- Results for 7.5 umol/L HCY: No. of Points 40, Mean (µM) 7.5, Within CV% 3.2%, Total CV% 3.4%.
- Results for 11.8 umol/L HCY: No. of Points 40, Mean (µM) 11.8, Within CV% 1.8%, Total CV% 3.5%.
- Results for 29.0 umol/L HCY: No. of Points 40, Mean (µM) 29.0, Within CV% 2.8%, Total CV% 3.3%.
- Precision studies at three POL sites: Two serum specimens were used at each POL site, run in 4 replicates per day for 5 days.
- Sample 1: No. of Points 20, Mean (µmol/L) 4.89, Within CV% 3.1%, Total CV% 5.2%.
- Sample 2: No. of Points 20, Mean (µmol/L) 10.68, Within CV% 2.8%, Total CV% 3.7%.
- Sample 3: No. of Points 20, Mean (µmol/L) 13.71, Within CV% 2.8%, Total CV% 4.1%.
- Sample 4: No. of Points 40, Mean (µmol/L) 29.83, Within CV% 3.5%, Total CV% 6.0%.
- Sample 5: No. of Points 20, Mean (µmol/L) 42.92, Within CV% 2.6%, Total CV% 3.2%.
- Additional precision study at three POL sites with multiple users: A total of 9 serum samples containing HCY levels ranging from low to high were used. At each site, 3 serum samples were tested by three different people, 4 times for 5 days.
- Site 1: Sample 1 (Mean 11.05 µmol/L, Total CV 7.0%), Sample 2 (Mean 25.82 µmol/L, Total CV 5.3%), Sample 3 (Mean 42.73 µmol/L, Total CV 6.4%).
- Site 2: Sample 1 (Mean 10.26 µmol/L, Total CV 6.6%), Sample 2 (Mean 25.18 µmol/L, Total CV 5.5%), Sample 3 (Mean 41.99 µmol/L, Total CV 4.4%).
- Site 3: Sample 1 (Mean 11.63 µmol/L, Total CV 6.0%), Sample 2 (Mean 26.34 µmol/L, Total CV 6.8%), Sample 3 (Mean 31.63 µmol/L, Total CV 5.5%).
- Linearity/assay reportable range: Ten levels of linearity set prepared by diluting a serum control containing 50μmol/L HCY with saline, tested in triplicate.
- Result: Recovered HCY = 0.9749 * Expected HCY + 0.751, R2 of 0.9992.
- Linearity range: 3 - 50 µmol/L.
- Traceability, Stability, Expected values:
- Calibrator traceable to NIST SRM 1955.
- Stability: Real time data showed HCY POC Test is stable for at least 10 months at 2-8℃ storage.
- LoB, LoD, LoQ: Determined according to CLSI EP17-A.
- LoB = 0.06 µmol/L, LoD = 0.32 umol/L, LoQ = 3.00 umol/L.
- Interference: Common endogenous substance interference tested with 12μM and 29μM HCY serum samples spiked with various concentrations of substances.
- Conclusion: Substances normally present in serum produced less than 10% deviation.
- Method comparison with predicate device: Individual serum samples tested in parallel with Diazyme HCY Two Reagent Enzymatic Assay on Olympus AU400.
- Sample size: 74.
- Regression results: Slope 0.9612, Intercept 0.5246, Correlation coefficient 0.9696, Range of values 4.17-49.50 μmol/L.
- External method comparison at three POL sites: 120 serum specimens (40 at each site) compared to Diazyme Enzymatic HCY Assay on Olympus AU400 (K061971).
- All combined: n 120, Slope 1.0552, Intercept -0.8860, R2 0.9765. Range 3.88-49.86.
- Matrix comparison: 40 sample sets serum/EDTA plasma/Li Heparin were tested on SMART analyzer.
- Results: Slope = 1.0197 and 0.9632 for EDTA plasma and Li Heparin respectively. R = 0.9889 and 0.99 for EDTA plasma and Li Heparin respectively.
- Conclusion: No matrix effect between serum, EDTA plasma and Li Heparin Plasma.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
Premarket approval Homocysteine PC
510(k) SUMMARY AND SUBSTANTIAL EQUIVALENCE COMPARISON
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitter's name: | Diazyme Laboratories | JUL 31 2012 |
|---|---|---|
| Submitter's address: | 12889 Gregg Court | |
| Poway, CA 92064 | ||
| USA | ||
| Name of Contact Person: | Dr. Abhijit Datta | |
| Diazyme Laboratories | ||
| 12889 Gregg Court | ||
| Poway, CA 92064 | ||
| Phone: 858-455-4762 | ||
| Fax: 858-455-2120 | ||
| Name of the Device | HCY POC Test | |
| Trade Name | HCY POC Test | |
| Common Usual Name | SMART Homocysteine Assay | |
| Device Classification Name | HCY POC Assay | |
| Product Code | LPS; Test, Homocysteine | |
| Panel | Clinical Chemistry (75) | |
| Submission Type | 510K | |
| Regulation Number | 21CFR 862.1377 | |
| Device Class | Class II (Assay) | |
| Predicate Device | Diazyme Homocysteine Assay | |
| K071971 | ||
| Establishment Registration | 2032900 |
Executive Summary
Detailed performance characteristics and comparison analysis are given in this filing and demonstrate substantial equivalence to predicate device that is currently being marketed. The performance characteristics of the Diazyme HCY POC Test Kit are substantially similar to that of the
1
approved predicate device DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT (K071971). Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the HCY POC Test and offers POL users an in vitro diagnostic device system to measure HCY in human serum/plasma samples.
Description of the Device:
Diazyme HCY POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Homocysteine (HCY) in human serum or plasma. Diazyme HCY POC Test is based on a novel enzyme cycling method as published in the Journal of Clinical Chemistry. In this assay, oxidized HCY is first reduced to free HCY which then reacts with a co-substrate, S-adenosylmethionine (SAM) catalyzed by a HCY S-methyltransferase to form methionine (Met) and S-adenosylhomocysteine (SAH). SAH is assessed by coupled enzyme reactions including SAH hydrolase, adenosine (Ado) deaminase and glutamate dehydrogenase, wherein SAH is hydrolyzed into adenosine (Ado) and HCY by SAH hydrolase. The formed HCY that is originated from the co-substrate SAM is cycled into the HCY conversion reaction by HCY S-methyltransferase. This forms a co-substrate conversion product-based enzyme cycling reaction system with signification of detection signals. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversion of NADH to NAD+. The concentration of HCY in the sample is indirectly proportional to the amount of NADH converted to NAD+ (ΔA340mm).
Diazyme Homocysteine POC Controls were cleared in previous FDA filing K042448.
SMART Analyzer (K092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuvette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37℃ and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.
The Diazyme HCY POC Test system thus consists of the following:
- HCY POC Test Kit. Reagents are provided in prefilled tubes, cuvettes and . cuvette caps. The DRS cuvette and cuvette caps can only work with the SMART analyzer.
- HCY POC Test Control Kit. Controls are provided for quality control of the . HCY POC Test.
2
2
Indication (s) for use
Diazyme's HCY POC Test Kit is intended to be used with the SMART analyzer in a Point-of-Care setting for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only.
| Table 1 Summary of Assay Kit Components | |||
|---|---|---|---|
| -- | -- | -- | ----------------------------------------- |
| Candidate device |
|---|
| Kit can ONLY be used with SMART Analyzers |
| Reagent 1 |
| 20 DRS cuvettes (prefilled) |
| • NADH and substrates, same as the predicate |
| Reagent 2 |
| 20 DRS caps (prefilled) |
| • Enzymes and stabilizers, same as the predicate |
| Calibrator |
| 1 x preprogrammed lot specific RFID card in each kit |
| Control Set |
| Control (serum based, read to use), same as the predicate |
Performance Characteristics:
Precision/Reproducibility
Precision study at manufacture site
The precision of the Diazyme HCY POC Assay was evaluated according to Clinical and Laboratory Standards Institute (CLSI) EP5-A guideline with some modifications. In the study, three serum controls containing 7.3, 11.87, and 29.32umol/L HCY were tested in duplicate, two runs per day, over ten working days. The first five days used Lot 1, HT00209, and subsequent five days used Lot 2, HT00309. This was performed on three different SMART Analyzers. The results indicated good precision and are summarized in the following table:
| | 7.3µmol/L
HCY | 11.87µmol/L
HCY | 29.32µmol/L
HCY |
|---------------|------------------|--------------------|--------------------|
| No. of Points | 40 | 40 | 40 |
| Mean (µM) | 7.5 | 11.8 | 29.0 |
| Within CV% | 3.2% | 1.8% | 2.8% |
| Total CV% | 3.4% | 3.5% | 3.3% |
3
Conclusion: Within precisions for three levels of HCY serum samples are 3.2% for 7.5μmol/L HCY, 1.8% for 11.87 µmol/L HCY, and 2.8% for 29.0 mol/L HCY. Total precisions (CV) for three levels of HCY serum samples are 3.4% for 7.5umol/L HCY, 3.5% for 11.87 umol/L HCY, and 3.3% for 29.0umol/L HCY. These results meet precision criteria.
Precision studies at three POL sites
The precision was also evaluated in three physician office laboratories (POL) by intended users such as nurses and office assistances to test systemic and random error on two Diazyme HCY SMART analyzers. Two serum specimens were used at each POL site, the two serum specimens were run in 4 replicates per day for 5 days. The results indicated good precision and are summarized in the following table:
| | Sample 1
Site 1 | Sample 2
Site 2 | Sample 3
Site 3 | Sample 4
Site 1 and 2 | Sample 5
Site 3 |
|-----------------------------------------|--------------------|--------------------|--------------------|--------------------------|--------------------|
| No. of Points | 20 | 20 | 20 | 40 | 20 |
| Mean ( $ \mu $ mol/L) | 4.89 | 10.68 | 13.71 | 29.83 | 42.92 |
| Within CV% | 3.1% | 2.8% | 2.8% | 3.5% | 2.6% |
| Total CV% | 5.2% | 3.7% | 4.1% | 6.0% | 3.2% |
The results are summarized in the following tables:
(3) Additional precision study was evaluated at three physician office laboratories (POL) with multiple users at each site. A total of 9 serum samples containing HCY levels ranging from low to high were used for the precision study. At each site, 3 serum samples were tested by three different people. Each sample was run 4 times for 5 days.
The results are summarized in the following tables: Site 1·
| Site 1. | Sample 1 | Sample 2 | Sample 3 |
|---|---|---|---|
| No. of Points | 20 | 20 | 20 |
| Mean (µmol/L) | 11.05 | 25.82 | 42.73 |
| Within run CV | 6.7% | 6.2% | 5.60% |
| Total CV | 7.0% | 5.3% | 6.4% |
Site 2:
| Sample 1 | Sample 2 | Sample 3 | |
|---|---|---|---|
| No. of Points | 20 | 20 | 20 |
| Mean (µmol/L) | 10.26 | 25.18 | 41.99 |
| Within run CV% | 6.9% | 5.2% | 3.8% |
| Total CV% - | 6.6% | 5.5% | 4.4% |
Site 3:
| - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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| Mean (µmol/L) | 11.63 | 26.34 | 31.63 |
|---|---|---|---|
| SD (µmol/L) | 0.4941 | 1.9883 | 1.8298 |
| Within run CV% | 4.2% | 7.5% | 5.8% |
| Total CV% | 6.0% | 6.8% | 5.5% |
Conclusion: For the 9 serum samples containing HCY from 10.26 µmol/L to 42.73 µmol/L, a CV% of less than 8% was obtained at the three POL sites.
Linearity/assay reportable range:
Ten levels of linearity set were prepared by diluting a serum control containing 50μmol/L HCY with saline according to Clinical and Laboratory Standards Institute (CLSI) EP6-A. The samples prepared were tested using the Diazyme's HCY POC Assay in triplicate. After linear regression, an equation of Recovered HCY = 0.9749 * Expected HCY + 0.751 and correlation coefficient R2 of 0.9992 were obtained.
The linearity of Diazyme HCY SMART Assay is linear 3 - 50 µmol/L.
Traceability, Stability, Expected values (controls, calibrators, or methods):
Calibrator
HCY POC Test calibration is traceable to the higher order NIST SRM 1955.
Calibration Radio Frequency Identification Card (RFID card)
HCY POC Test utilizes a RFID card that is preprogrammed with a reagent lot specificcalibration curve and is supplied in each kit. When RFID card is inserted into SMART analyzer slot (assay procedure step), the lot specific calibration curve is automatically utilized for assay test. RFID cards are programmed at the manufacturer site and are subject to the same quality control checks as the reagents and controls.
Lot specific calibrator values to be generated for RFID card calibration curve programming are traced to reference Diazyme Homocysteine calibrator values (K071971) and are value assigned as follows:
- · To construct Diazyme HCY SMART Assay RFID card calibration curve, 5 levels of calibrators used in the predicate device (K071971) are tested with the Diazyme HCY POC Test reagents on SMART analyzers to obtain the rate of absorbance change. The calibrator value and the mean of absorbance change are programmed into cards by using a card writer.
- · After creation of the RFID card it is used for in process and final QC testing (Step 3: Final calibration values). Tests include NIST SRM 1955, Diazyme Homocysteine Controls, and serum samples.
5
Stability
Two lots of the Diazyme HCY POC Assay reagents were used for this study. The reagents from each lot were kept 2-8°C refrigerator. In the study, two levels of serum control samples containing 7.31 uM. and 29.53 uM homocysteine were tested. At indicated time, the Diazyme HCY POC Assay reagents were removed from storage and tested. The real time data so far showed that the HCY POC Test is stable for at least 10 months at 2-8℃ storage. The real time stability testing is on-going.
LoB, LoD,LoQ
The LoB, LoD, and LoQ of the Diazyme HCY POC Test Kit were determined according to CLSI EP17-
A. LoB = 0.06 µmol/L LoD = 0.32 umol/L LoQ = 3.00 umol/L.
Interference
Common endogenous substance interference
The level of interference from the substances normally present in the serum was determined by using Diazyme Homocysteine SMART Enzymatic Assay to test 12μM and 29μM HCY serum samples spiked with various concentrations of substances following Clinical and Laboratory Standards Institute EP7-A "Interference Testing in Clinical Chemistry": dose-response guidelines.
| Interference | Concentration |
|---|---|
| Ascorbic Acid | 10mmol/L |
| Unconjugated Bilirubin | 40mg/dL |
| Conjugated Bilirubin | 40mg/dL |
| Hemoglobin | 500mg/dL |
| Triglyceride | 1000mg/dL |
| Glutathione | 500 µM |
| Methionine | 20 µM |
| Cysteine | 1000 μM |
| Pyruvate | 500 µM |
| Cystathionine | 100 µM |
| Hydroxylamine | 1000 μM |
| Carbamezapine | 130 µM |
| Methotrexate | 2.0 mM |
| Phenytoin | 200 µM |
| 6-azauridine triacetate | 1000 µM |
| S-adenosyl-methionine | 20 µM |
| Carbamezapine-10, 11-epoxide | 60 µM |
| Ethosuximide | 1800 µM |
6
| Primidone | 200 $ μ $ M |
|---|---|
| Valporic Acid | 3.5 mM |
| Sodium Nitrate | 500 $ μ $ M |
Conclusion: The following substances normally present in serum produced less than 10% deviation when tested at levels equal to the concentrations listed below
Comparison Studies
Method comparison with predicate device
To demonstrate accuracy, the Diazyme HCY Enzymatic SMART Assay was tested with individual serum samples and run in parallel with the Diazyme HCY Two Reagent Enzymatic Assay on the Olympus AU400.
Serum samples were used for the comparison experiment. To ensure the concentrations of HCY distributed across the reportable dynamic range, additional HCY samples used for the study were spiked with stock solution of HCY to targeted concentrations.
The regression results are summarized in the following table:
| application | |
|---|---|
| n | 74 |
| Slope . | 0.9612 |
| Intercept | 0.5246 |
| Correlation coefficient | 0.9696 |
| Range of values | 4.17-49.50 μmol/L |
The method comparison study was performed externally at the three POL sites. One Hundred and Twenty (120) serum specimens are used in total (40 samples at each site). The Diazyme HCY POC reagents were used to test individual serum samples with comparison to Diazyme Enzymatic HCY Assay on Olympus AU400 (K061971).
| SMART HCY | Site 1 | Site 2 | Site 3 | All combined |
|---|---|---|---|---|
| n | 40 | 40 | 40 | 120 |
| Slope | 1.0890 | 1.0041 | 1.0600 | 1.0552 |
| Intercept | -0.7438 | -0.6251 | -1.1564 | -0.8860 |
| R2 | 0.9830 | 0.9645 | 0.9819 | 0.9765 |
The regression results are summarized in the following table
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Matrix comparison
To evaluate the anticoagulant effects of EDTA plasma and Li Heparin Plasma of the HCY levels, 40 sample sets serum/EDTA plasma/Li Heparin were tested on SMART analyzer using HCY POC Test Kits.
Results: Slope = 1.0197 and 0.9632 for EDTA plasma and Li Heparin respectively, and R = 0.9889 and 0.99 for EDTA plasma and Li Heparin respectively.
Conclusion: There is no matrix effect between serum, EDTA plasma and Li Heparin Plasma.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
10903 New Hampshire Avenue Silver Spring, MD 20993
Diazyme Laboratories c/o Abhijit Datta 12889 Gregg Court Poway, CA 92064
JUL 3 1 2012
Re: K121053
Trade Name: Diazyme Homocysteine POC Test Regulation Number: 21 CFR §862.1377 Regulation Name: Urinary Homocysteine (non-quantitative) test system Regulatory Class: Class II Product Codes: LPS Dated: July 11, 2012 Received: July 13, 2012
Dear Dr. Datta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device
Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (If Known):
Device Name: Diazyme Homocysteine POC Test Kit
Indications for Use:
Diazyme's HCY POC Test Kit is intended to be used with the SMART analyzer in a Point-of-Care setting for the in vitro quantitative determination of total L-homocysteine in serum or plasma. The assay can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. For in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Ruch chule
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
121053 510(k)
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