(251 days)
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No
The summary describes a standard immunoassay technology and performance metrics, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for quantitative measurement of vancomycin levels in patient samples, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is used in the diagnosis and treatment of vancomycin overdose."
No
The device is an in vitro diagnostic (IVD) assay that uses chemical reactions and paramagnetic microparticles to measure vancomycin levels. While it runs on the ARCHITECT i System (which likely includes software), the core of the device is a chemical assay kit, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma..."
This statement clearly indicates that the device is intended for use outside of the body (in vitro) to analyze human samples (serum or plasma) for diagnostic purposes (diagnosis and treatment of vancomycin overdose and monitoring levels). This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
LEH
Device Description
The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: Vancomycin samples were tested for precision following the CLSI protocol EPS-A2. In the study, the total run %CV was = 5 µg/mL demonstrated cross-reactivity with samples containing vancomycin in the measurement range. CDP-1 may accumulate in patients with impaired renal function. The following compounds were tested in the absence of vancomycin after adding 500 ug/mL of each compound (except Methotrexate, Isoniazid and CDP-1) to human serum. Isoniazid was tested at 300 ug/mL. Methotrexate was tested at 227 ug/mL. Cross-reactivity of each compound was less than 0.42 µg/mL. The same compounds (except CDP-1 and Isoniazid) at the concentrations tested demonstrated no interference in the presence of vancomycin using the acceptance criteria of % recovery within 100 ± 10%. Interference was observed for CDP-1 and Isoniazid in the presence of vancomycin as follows: CDP-1 at > 5 µg/mL interferes with samples containing vancomycin in the measurement range. Isoniazid at > 300 ug/mL interferes with samples containing vancomycin in the measurement range.
Method Comparison: The new ARCHITECT i Vancomycin assay (LN 1P30-28) correlated with the predicate ARCHITECT i Vancomycin assay (LN 1P30-25) with a Correlation Coefficient (r) of 0.99 (95% CI: 0.99, 0.99), Slope of 1.04 (95% CI: 1.01, 1.07), and Intercept of -0.23 (95% CI: -0.87, 0.36) for 107 observations in the specimen concentration range of 7.34-47.49 µg/mL (predicate) and 7.69-48.60 µg/mL (subject).
Measuring Interval: For the verification studies described in the reagent package insert, the measuring interval range is 3.0 µg/mL to 50.0 µg/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoB: 0.27 ug/mL
LoD: 0.42 ug/mL
LoQ: 2.50 ug/mL
Overall percent recovery: 100.2%
Percent recovery range: 98.0% to 105.4% for vancomycin concentrations from 5 to 45 ug/mL.
Percent recovery: 86.4% for vancomycin concentration 3.2 µg/mL.
Mean recovery observed during interference study: 93.0% to 104.5%.
Cross-reactivity of CDP-1 (10 ug/mL) in absence of vancomycin: less than 0.42 µg/mL.
Cross-reactivity of tested compounds (except Methotrexate, Isoniazid and CDP-1) in absence of vancomycin: less than 0.42 µg/mL.
Correlation Coefficient (r): 0.99
Slope: 1.04
Intercept: -0.23
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
KI23947
510(k) Summary
The summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
Company and Contact Name
Mr. Joan Guixer, Director of Quality Assurance and Regulatory Affairs Biokit S.A. Llica d'Amunt Barcelona, Spain 08186 Phone: +34657883347/+34 93 860 9000 Fax: +34 93 860 9029
AUG 2 9 2013
Date Prepared: August 27, 2013
Regulatory Declarations
| Common/Usual Name | Vancomycin Test |
|---|---|
| Trade/Proprietary Name | ARCHITECT i Vancomycin |
| Classification Regulation | 21 CFR 862.3950 |
| Device Class | Class II |
| Device Regulation Panel | Toxicology |
| Product Code | LEH |
Indications for Use
The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
Legally Marketed Device to Which Equivalency is Claimed
The ARCHITECT i Vancomycin assay (LN 1P30-28) is substantially equivalent to the previously cleared ARCHITECT i Vancomycin assay (LN 1P30-25, K072036).
1
Device Description
The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.
Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.
Comparison of Technological Characteristics
Both the submission (ARCHITECT i Vancomycin [LN 1P30-28]) and predicate (ARCHITECT i Vancomycin [LN 1P30-25]) device use a chemiluminescent microparticle immunoassay (CMIA) technology for the quantitative measurement of vancomycin in human serum and plasma.
Summary of Performance Testing
Precision
Vancomycin samples were tested for precision following the CLSI protocol EPS-A2. In the study, the total run %CV was ≤ 10% and meets the design acceptance criteria.
Recovery
Serum samples were spiked with vancomycin at concentrations across the assay range. The overall percent recovery of the ARCHITECT i Vancomycin assay was 100.2%. The percent recovery ranged from 98.0% to 105.4% for vancomycin concentrations from 5 to 45 ug/mL. The percent recovery was 86.4% for vancomycin concentration 3.2 µg/mL.
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Interferences
Serum specimens with vancomycin levels from 4.4 to 48.8 µg/mL were supplemented with the following potentially interfering compounds. The mean recovery observed during the study ranged from 93.0% to 104.5%.
- . Triglycerides, 2500 mg/dL
- . Hemoglobin, 400 mg/dL
- Bilirubin, 20 mg/dL .
- Low Protein, 3 g/dL .
- High Protein, 12 g/dL •
- . HAMA, 1000 ng/mL
- Rheumatoid Factor, 500 IU/mL
Linearity
Samples were tested to demonstrate linearity throughout the assay range. A linear range of
3.0 ug/mL to 50.0 ug/mL was established for the ARCHITECT i Vancomycin assay.
Sensitivity
In this study, the Limit of Blank (LoB) was 0.27 ug/mL, Limit of Detection (LoD) was
0.42 ug/mL and Limit of Quantitation (LoQ) was 2.50 ug/mL.
Matrix Comparison
The specimen collection tubes listed below were verified to be used with the ARCHITECT i Vancomycin assay.
- Human serum .
- . Human plasma collected in:
- . Lithium heparin
- . Dipotassium EDTA
- . Sodium Citrate
- . Sodium Heparin
- . Sodium Fluoride/Potassium Oxalate
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Specificity
A study has demonstrated that vancomycin crystalline degradation product 1 (CDP-1) at a concentration of 10 ug/mL, has cross-reactivity less than 0.42 µg/mL in the absence of vancomycin. CDP-1 at ≥ 5 µg/mL demonstrated cross-reactivity with samples containing vancomycin in the measurement range. CDP-1 may accumulate in patients with impaired renal function.
The following compounds were tested in the absence of vancomycin after adding 500 ug/mL of each compound (except Methotrexate, Isoniazid and CDP-1) to human serum. Isoniazid was tested at 300 ug/mL. Methotrexate was tested at 227 ug/mL. Cross-reactivity of each compound was less than 0.42 µg/mL. The same compounds (except CDP-1 and Isoniazid) at the concentrations tested demonstrated no interference in the presence of vancomycin using the acceptance criteria of % recovery within 100 ± 10%. Interference was observed for CDP-1 and Isoniazid in the presence of vancomycin as follows:
- . CDP-1 at > 5 µg/mL interferes with samples containing vancomycin in the measurement range.
- . Isoniazid at > 300 ug/mL interferes with samples containing vancomycin in the measurement range.
| Acetaminophen | Clindamycin | Heparin | Nitrofurantoin | Sulfamethoxazole |
|---|---|---|---|---|
| Amikacin | Chloramphenicol | Hydrocholorothiazide | Penicillin G | Tetracycline |
| Amphotericin B | Chlorothiazide | Ibuprofen | Penicillin V | Ticarcillin |
| Ampicillin | Ciprofloxacin | Isoniazid | Prednisolone | Tobramycin |
| Caffeine | Erythromycin | Kanamycin B | Rifampin | Trimethoprim |
| CDP-1 | Ethambutol | Methotrexate | Salicylic acid | |
| Cefotaxime | 5-Fluorocytosine | Methylprednisolone | Spectinomycin | |
| Cephalexin | Furosemide | Naproxen | Streptomycin | |
| Cephalothin | Gentamicin | Neomycin | Sulfadiazine |
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Method Comparison
The new ARCHITECT i Vancomycin assay (LN 1P30-28) correlated with the predicate ARCHITECT i Vancomycin assay (LN 1P30-25) as shown in the table below:
| Specimen Concentration Range
(µg/mL) | | Number of
Observations | Correlation
Coefficient (r)
(95% CI) | Slope
(95% CI) | Intercept
(95% CI) |
|-----------------------------------------|------------|---------------------------|--------------------------------------------|--------------------|-----------------------|
| LN 1P30-25 | LN 1P30-28 | | | | |
| 7.34-47.49 | 7.69-48.60 | 107 | 0.99
0.99, 0.99 | 1.04
1.01, 1.07 | -0.23
-0.87, 0.36 |
Measuring Interval
For the verification studies described in the reagent package insert, the measuring interval range is 3.0 µg/mL to 50.0 µg/mL.
Conclusion
Substantial equivalence of the proposed device to the previously cleared ARCHITECT i Vancomycin assay (K072036) has been demonstrated through performance testing to verify that the device functions as intended and design specifications have been satisfied.
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Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6(19 Silver Spring, MD 20993-0002
August 29, 2013
Biokit S.A. C/O Joan Guixer Can Malé S/N Llica d'Amunt, Barcelona, 08186, SPAIN
Re: K123947
Trade/Device Name: ARCHITECT iVancomycin Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: II Product Code: LEH Dated: July 23, 2013 Received: July 25, 2013
Dear Mr. Guixer:
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 Part 801); 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 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 go to http://www.fda.gov/AhoutFDA/CentersOffices/CDRH/CDRHOffices/uem115809.htm for
6
Page 2-Mr. Guixer
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
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): K123947
Device Name: ARCHITECT i Vancomycin
Indications for Use:
Reagents
The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy ..
For in vitro diagnostic use.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Denise Johnson-lyles -S 2013.08.28 13:21:25 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123947