(90 days)
Not Found
No
The device description details a standard immunoassay technique (PETINIA) and does not mention any computational methods that would involve AI or ML. The performance studies focus on traditional analytical validation metrics.
No
The device is an in vitro diagnostic assay used to measure vancomycin levels in patient samples for diagnosis and treatment monitoring, not to directly treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use..." and "Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy." This directly indicates its role in diagnosis.
No
The device is an in vitro diagnostic assay and calibrator, which are physical reagents used in a laboratory setting. The description details a chemical reaction (PETINIA) and measurement of turbidimetric readings, indicating a hardware component (the Trinidad CH System) is required for its function. There is no mention of the device being solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma..." This is the most direct indicator.
- Device Description: The description details a laboratory test method (homogeneous particle enhanced turbidimetric inhibition immunoassay) performed on human samples (serum or plasma).
- Intended User/Care Setting: The intended users are "laboratory technicians," which aligns with the typical setting for in vitro diagnostic testing.
- Performance Studies: The performance studies described (Detection Limit, Linearity, Precision, Interferences, Method Comparison, Matrix Equivalency) are standard types of studies conducted to validate the performance of an in vitro diagnostic assay.
- Predicate Device(s): The mention of predicate devices (K963267 Vancomycin Flex Reagent Cartridge; K033809 Dimension Drug Calibrator II) which are also IVDs further confirms the nature of this device.
All of these elements strongly indicate that the Trinidad CH Vancomycin assay and its associated calibrator are intended for use in a laboratory setting to diagnose or monitor medical conditions using samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Trinidad CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is intended for in vitro diagnostic use in the calibration of Vancomycin (Vanc) on the Trinidad CH System.
Product codes
LEH, DLJ
Device Description
TRINIDAD CH VANCOMYCIN (VANC)
The Trinidad CH Vancomycin (Vanc) assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 nm and 694 nm.
Reaction Equation:
Vancomycin + PR + Ab → PR-Ab complex + Vancomycin-Ab (scatters light at 545 nm)
Serum and lithium heparin plasma specimens may be used. The reagent is stored unopened at 2 - 8 °C and is stable for use on system for 30 days. Calibration is performed every 30 days for a reagent lot or every 7 days for an individual pack.
TRINIDAD CH DRUG3 CALIBRATOR (DRUG3 CAL)
The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is a 5 level calibrator product prepared from bovine serum base product. The product is stored at 2 - 8 °C. The Trinidad CH Drug 3 Calibrator is stable for 15 days at 2 – 8 °C after being opened and securely recapped.
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
Laboratory technicians with training similar to personnel who would conduct the tests in a hospital laboratory 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
-
Detection Limit:
- Study Type: Evaluation of Limit of Blank (LoB) and Limit of Detection (LoD).
- Sample Size: 60 measurements (4 samples, N=5, for 3 days, one run per day, 3 reagent lots for LoB; 4 low serum samples, N=5, for 3 days, one run per day, 3 reagent lots for LoD).
- Key Results: LoB was 0.1 µg/mL. LoD was 0.2 µg/mL.
- Protocol: CLSI EP17-A2.
-
Limit of Quantitation (LoQ):
- Study Type: Determination of LoQ for serum.
- Sample Size: Not explicitly stated as one sample size, but involved 4 low serum samples processed on three reagent lots for three days, on one instrument for a total of 60 measurements per reagent lot, leading to a total of 180 determinations.
- Key Results: Measured LoQ was 2.8 µg/mL, supporting a claim of 3.0 µg/mL with a total error of ≤ 20%.
- Protocol: CLSI Document EP17-A2.
-
Linearity Study:
- Study Type: Evaluation of linearity across the assay measuring interval.
- Sample Size: 10 samples, each measured in 6 replicates.
- Key Results: The assay was linear across the measuring interval (0.9 to 51.1 µg/mL). Nonlinear coefficients were nonsignificant (all p values ≥ 0.05), or if significant, allowable bias was ≤ 0.5 µg/mL or 10%, whichever was greater. All observed biases were within allowable limits.
- Protocol: CLSI Evaluation of the Linearity of Quantitative Measurement Procedure (EP06-A).
-
Precision Studies:
- Study Type: Evaluation of precision performance.
- Sample Size: 80 replicates (n = 2 replicates, two times a day for at least 20 days) with controls, serum, and plasma pools.
- Key Results:
- Serum QC (6.4 µg/mL): Repeatability SD 0.16 µg/mL (CV 2.6%); Within-Lab SD 0.18 µg/mL (CV 2.7%).
- Serum (11.2 µg/mL): Repeatability SD 0.20 µg/mL (CV 1.8%); Within-Lab SD 0.23 µg/mL (CV 2.0%).
- Serum QC (17.5 µg/mL): Repeatability SD 0.28 µg/mL (CV 1.6%); Within-Lab SD 0.35 µg/mL (CV 2.0%).
- Serum (32.7 µg/mL): Repeatability SD 0.46 µg/mL (CV 1.4%); Within-Lab SD 0.67 µg/mL (CV 2.0%).
- Plasma (45.8 µg/mL): Repeatability SD 0.78 µg/mL (CV 1.7%); Within-Lab SD 0.83 µg/mL (CV 1.8%).
- Protocol: CLSI EP05-A3.
-
Interferences:
- Study Type: Interference testing.
- Sample Size: Not explicitly stated, but involved spiking compounds into fresh sample pools at low (10.0 µg/mL Vanc) and high (40.0 µg/mL Vanc) analyte concentrations.
- Key Results: No interference was detected at the following concentrations: Hemoglobin 600 mg/dL, Conjugated Bilirubin 20 mg/dL, Unconjugated Bilirubin 20 mg/dL, Lipemia (Intralipid) 1000 mg/dL. Vancomycin crystalline degradation product (CDP-1) at 20 µg/mL demonstrated cross-reactivity (21.0% at 0 µg/mL Vanc and 19.1% at 10 µg/mL Vanc).
- Protocol: CLSI EP7-A2.
-
Method Comparison:
- Study Type: Comparison with predicate device (Dimension RxL VANC assay).
- Sample Size: 100 remnant de-identified samples (native, spiked, and diluted).
- Regression Equation: y = 1.04x - 1.04 µg/mL
- Correlation Coefficient (r): 0.997
- Sample Interval: 4.4-48.1 µg/mL
- Key Results: Demonstrated good agreement between the Trinidad CH Vancomycin (Vanc) and the predicate Dimension RxL VANC assay.
- Protocol: CLSI EP09-A3.
-
Matrix Equivalency:
- Study Type: Serum and lithium heparin plasma equivalency.
- Sample Size: 60 matched samples (some diluted or spiked).
- Regression Equation: For Plasma (Lithium heparin) vs. Trinidad CH Vanc – Serum: y = 1.00x + 0.49 µg/mL
- Correlation Coefficient (r): 0.990
- Sample Interval: 4.0–43.3 µg/mL
- Key Results: Demonstrated equivalency between serum and lithium heparin plasma matrices.
Key Metrics
- LoB: 0.1 µg/mL
- LoD: 0.2 µg/mL
- LoQ: 2.8 µg/mL (claim of 3.0 µg/mL)
- Linearity Performance: Bias ≤ 0.5 µg/mL or 10% (whichever is greater) for significant nonlinear coefficients.
- Precision (CV%): Ranging from 1.4% to 2.7% for different concentrations and specimen types.
- Interference (Bias%): Bias exceeding 10% considered interference.
- Method Comparison (r): 0.997
- Matrix Equivalency (r): 0.990
Predicate Device(s)
Vancomycin Flex Reagent Cartridge (K963267), Dimension Drug Calibrator II (K033809)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2016
SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA J. DUGGAN REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE, PO BOX 6101 MS 514 NEWARK, DE 19711 US
Re: K160202
Trade/Device Name: Trinidad CH Vancomycin (Vanc) Trinidad CH Drug 3 Calibrator (DRUG3 CAL) Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH, DLJ Dated: January 27, 2016 Received: January 28, 2016
Dear Ms. Duggan,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160202
Device Name Trinidad CH Vancomycin (Vanc) Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Indications for Use (Describe)
The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Trinidad CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is intended for in vitro diagnostic use in the calibration of Vancomycin (Vanc) on the Trinidad CH System.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
ASSIGNED 510(K) NUMBER
The assigned 510(k) number is
APPLICANT AND DATE
Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: laura.j.duggan@siemens.com Phone: 302-631-7654 Fax: 302-631-6299
March 29, 2016
MANUFACTURER
Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235
REGULATORY INFORMATION
Regulatory Submission for the Trinidad CH Vancomycin (Vanc) and Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
| Common Name: | Clinical Toxicology Test Systems | Clinical Toxicology Test Systems |
|---|---|---|
| Proprietary Name: | Trinidad CH Vancomycin (Vanc) | |
| Assay | Trinidad CH Drug 3 Calibrator | |
| (DRUG3 CAL) | ||
| Classification | ||
| Name: | Vancomycin test system | Clinical Toxicology Calibrator |
| Regulation | ||
| Number: | 21CFR862.3950 | 21CFR862.3200 |
| Classification: | Class II | Class II |
| Product Code: | LEH | DLJ |
| Panel: | Toxicology | Toxicology |
| Predicate Device: | Vancomycin Flex Reagent | |
| Cartridge (K963267) | Dimension Drug Calibrator II | |
| (K033809) |
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DEVICE DESCRIPTION
TRINIDAD CH VANCOMYCIN (VANC)
The Trinidad CH Vancomycin (Vanc) assay is based on a homogeneous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique which uses a synthetic particle-vancomycin conjugate (PR) and monoclonal vancomycin specific antibody (Ab). Vancomycin present in the sample competes with vancomycin on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of vancomycin in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 545 nm and 694 nm.
Reaction Equation
Vancomycin + PR + Ab
PR-Ab complex + Vancomycin-Ab (scatters light at 545 nm)
..............................................................................................................................................................................
Serum and lithium heparin plasma specimens may be used. The reagent is stored unopened at 2 - 8 °C and is stable for use on system for 30 days. Calibration is performed every 30 days for a reagent lot or every 7 days for an individual pack.
TRINIDAD CH DRUG3 CALIBRATOR (DRUG3 CAL)
The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is a 5 level calibrator product prepared from bovine serum base product. The product is stored at 2 - 8 °C. The Trinidad CH Drug 3 Calibrator is stable for 15 days at 2 – 8 °C after being opened and securely recapped.
INTENDED USE/INDICATIONS FOR USE
TRINIDAD CH VANCOMYCIN (VANC)
The Trinidad CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Trinidad CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
TRINIDAD CH DRUG3 CALIBRATOR (DRUG3 CAL)
The Trinidad CH Drug 3 Calibrator (DRUG3 CAL) is intended for in vitro diagnostic use in the calibration of Vancomycin (Vanc) on the Trinidad CH System.
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Below is a features comparison for the Trinidad CH system Vancomycin assay and the DRUG3 calibrator vs. their predicates:
| Feature | Predicate Device:
Dimension® VANC Flex®
reagent Cartridge (K963267) | New Device:
Trinidad CH Vancomycin
(VANC) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use : | The VANC assay used on the
Dimension clinical chemistry
system is an in vitro
diagnostic test intended to
measure vancomycin, a
glycopeptide antibiotic in
human serum or plasma. | For in vitro diagnostic use
in the quantitative
measurement of
vancomycin in human
serum or plasma on the
Trinidad CH System. |
| Indications for Use: | VANC test results may be
used in the diagnosis and
treatment of vancomycin
overdose and in monitoring
levels of vancomycin to
ensure appropriate therapy. | Same |
| Device Technology: | Homogeneous particle
enhanced turbidimetric
inhibition immunoassay
(PETINIA) technique | Same |
| Sample Type: | Serum/ Lithium Heparin
plasma | Same |
| Therapeutic Interval: | Peak Intervals: Samples from
adult volunteers drawn two
hours after the completion of
a 60 minute infusion of
vancomycin ranged from 18 –
26 µg/mL.
Samples drawn one hour
after the completion of a 60 | Same |
| | | |
| | minute vancomycin infusion ranged from 25 – 40 µg/mL. Samples drawn 30 minutes after the completion of a 60 minute infusion of vancomycin ranged from 30 – 40 µg/mL. Trough Intervals: Samples should be drawn just before the next dose. A trough interval of 5 - 10 µg/mL is recommended. | |
| Standardization: | Traceable to United States Pharmacopeia (USP) standards. | Same |
| Calibration Frequency: | 30 days | Same |
| Analytical Measuring Interval: | 0.0 – 50.0 µg/mL | 3.0–50.0 µg/mL |
| Interferences: | Bilirubin (Unconjugated) – 80 mg/dL
Lipemia (Intralipid®) – 200 mg/dL
Hemoglobin - 1000 mg/dL | Bilirubin (Conjugated & Unconjugated) – 20 mg/dL
Lipemia (Intralipid®) – 1000 mg/dL
Hemoglobin - 600 mg/dL |
| Calibrators: | Drug Calibrator II (K033809) | Drug 3 Calibrator |
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| Feature | Predicate Device:
Dimension Drug Calibrator
II (K033809) | New Device:
Trinidad CH Drug 3
Calibrator (DRUG3 CAL) |
|---------------------------------|----------------------------------------------------------------|-------------------------------------------------------------|
| Calibrator Matrix: | Bovine Serum Base | Same |
| Calibrator Form: | Liquid | Same |
| Number of Calibrator
Levels: | Five | Same |
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Assay performance comparison results for the Trinidad CH Vancomycin (Vanc) with the Trinidad CH Drug 3 Calibrator were obtained by processing the appropriate body fluids. Summary statistics for each are provided. These data demonstrate substantial equivalency of the Trinidad CH Vancomvcin (Vanc) with the Trinidad CH Drug 3 Calibrator versus the predicate devices. The following data represent typical assay performance.
DETECTION LIMIT
The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline.
Assessment of LoB was the 95th percentile of all values (sorted from lowest to highest), using non-parametric approach.
LoB Rank Position = 0.5 +0.95*B, where B=total reps=60; Rank = 57.5
| Trinidad CH Vancomycin (Vanc) - Limit of Detection Results | ||
|---|---|---|
| Limit | Protocol | Result |
| LoB | 4 samples with no analyte | |
| (bovine serum base) were | ||
| tested (N=5) for 3 days, | ||
| one run per day, 3 reagent | ||
| lots, | 0.1 µg/mL | |
| LoD | 4 low serum samples were | |
| tested (N=5) for 3 days, | ||
| one run per day, 3 reagent | ||
| lots | 0.2 µg/mL |
The nonparametric approach described in EP17-A2 was followed to determine the Limit of Detection.
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The Limit of Quantitation (LoQ) for serum was determined as described in CLSI Document EP17-A2. Total Error is calculated using: TE = bias + 2 * SD.
Four low serum samples were processed on three reagent lots for three days, on one instrument for a total of 60 measurements per reagent lot. The measured LoQ was 2.8 ug/mL in support of the LoQ claim of 3.0 µg/mL based a total of 180 determinations with a total error of ≤ 20%.
LINEARITY STUDY
Linearity was evaluated with 10 samples which spanned the assay measuring interval. Each was prepared by mixing high and low concentration samples across the measurement interval as described in CLSI Evaluation of the Linearity of Quantitative Measurement Procedure (EP06-A). The high sample was prepared by spiking native serum with purified vancomycin hydrochloride. The low sample was normal human serum. Six replicates were measured for each sample. The mean of these replicates was used for the calculations.
The assay was considered linear across the measuring interval if the nonlinear coefficients are nonsignificant (all p values are ≥ 0.05). If one or more of them are significant (p