(170 days)
BRAHMS PCT LIA Assay
Not Found
No
The description details a standard immunoassay technique (ELFA) performed on an automated instrument. The results are calculated based on calibration curves, which is a standard analytical method, not indicative of AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is an in vitro diagnostic test used to aid in risk assessment for critically ill patients; it does not directly treat or provide therapy.
Yes
The device aids in risk assessment for critically ill patients to determine progression to severe sepsis and septic shock by measuring human procalcitonin levels, which is a diagnostic function.
No
The device description clearly outlines a physical instrument (VIDAS® instrument) and physical components (Solid Phase Receptacle, reagent strips) used in an automated immunoassay process. While software is involved in controlling the instrument and calculating results, the core functionality and components are hardware-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "determination of human procalcitonin in human serum or plasma" using a laboratory technique (ELFA). This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information about a patient's health status.
- Device Description: The description details a laboratory assay performed on an automated instrument using reagents and analyzing a biological sample (serum or plasma). This aligns with the nature of an IVD.
- Clinical Studies: The document includes performance studies comparing the device to a predicate device and evaluating its performance in healthy subjects. This type of clinical validation is a requirement for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" (BRAHMS PCT LIA Assay) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
Therefore, based on the provided information, the VIDAS® BRAHMS PCT is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS BRAHMS PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay). VIDAS BRAHMS PCT is intended for use in conjunction with othe laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission, for progression to severe sepsis and septic shock.
Product codes
NTM
Device Description
The VIDAS BRAHMS PCT Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS® instrument.
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips.
All of the assay steps are performed automatically by the instrument. The sample is transferred into the wells containing anti-procalcitorin antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbellifery| phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the instrument in relation to two calibration curves corresponding to the two revelation steps and stored in memory, and then printed out.
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
critically ill patients on their first day of ICU admission
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical (Analytical) Comparison
Matrix Comparison:
Serum similar to Plasma
For a given patient, the same type of sample tube must be performed for each patient
Precision/Reproducibility:
6 samples tested in duplicate over 20 days
total precision: 6.17 - 15.31% CV
intra-run precision: 1.93 - 4.61% CV
inter-run precision: 3.57 - 7.04% CV
inter-site precision: 4.21 - 11.40% CV
Analytical Detection Limit: 2 ng/ml = high risk of severe sepsis and/or septic shock;
§ 866.3210 Endotoxin assay.
(a)
Identification. An endotoxin assay is a device that uses serological techniques in whole blood. The device is intended for use in conjunction with other laboratory findings and clinical assessment of the patient to aid in the risk assessment of critically ill patients for progression to severe sepsis.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance entitled “Class II Special Controls Guidance Document: Endotoxin Assay.” See § 866.1(e) for the availability of this guidance document.
0
J 1 2007
510(k) SUMMARY
VIDAS® B-R.A.H.M.S PCT Assay
| A. Submitter Information | |
|---|---|
| Submitter's Name: | bioMérieux, Inc. |
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nikita S. Mapp |
| Phone Number: | 314-731-7474 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | March 1, 2007 |
| B. Device Name | |
| Trade Name: | VIDAS® BRAHMS PCT |
| Common Name: | Endotoxin Assay |
| Classification Name: | 21 CFR 866.3210, Product Code NTM |
| Antigen, Inflammatory Response Marker, Seps | |
| C. Predicate Device Name | |
| Trade Name: | BRAHMS PCT LIA Assay |
D. Device Description
The VIDAS BRAHMS PCT Assay is an enzyme-linked fluorescent immunoassay (ELFA) performed in an automated VIDAS® instrument.
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), serves as the solid phase as well as the pipetting device for the assay. Reagents for the assay are ready-to-use and pre-dispensed in the sealed reagent strips.
All of the assay steps are performed automatically by the instrument. The sample is transferred into the wells containing anti-procalcitorin antibodies labeled with alkaline phosphatase (conjugate). The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbellifery| phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the
1
hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the instrument in relation to two calibration curves corresponding to the two revelation steps and stored in memory, and then printed out.
E. Intended Use
VIDAS BRAHMS PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay). VIDAS BRAHMS PCT is intended for use in conjunction with othe laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission, for progression to severe sepsis and septic shock.
F. Technological Characteristics Summary
A comparison of the similarities and differences of the assays is presented in the table below.
| IDAS BRAHMS PCT | BRAHMS POWER | |
|---|---|---|
| Intended Use | Determination of human procalcitonin in | |
| human serum or plasma (lithium heparin) | Same | |
| Indications for Use | For use in conjunction with other laboratory | |
| findings and clinical assessments to aid in | ||
| the risk assessment of critically ill patients | ||
| on their first day of ICU admission, for | ||
| progression to severe sepsis and septic | ||
| shock | Same | |
| Specimen | Human serum or plasma (lithium heparin) | Same |
| Analyte | Measures procalcitonin concentration | Same |
| Antibody | Anti-PCT antibody (monoclonal mouse) | Same |
| Assay Principle | Immunoassay based on sandwich principle | Immunoluminometric assay based |
| on sandwich principle | ||
| Automated | Automated assay | Non-automated assay |
| Final Detection of PCT | ||
| antigen | Fluorescence (ELFA) of 4-methyl- | |
| umbelliferyl measured at 450 nm | Luminescence signal | |
| measurement via luminometer | ||
| Assay Technique | Enzyme-Linked Fluorescent Assay(ELFA) | Immunoluminometric assay (ILMA) |
| Special instrument | ||
| requirements | None | Luminometer required |
| Sample Volume | 200 µl | 20 pl |
| Assay Time | ~20 minutes | ~90 minutes |
| Measurement range | 0.05 to 200 ng/ml | 0.3 - 500 ng/ml |
| Device | ||
| [VIDAS BRAHMS PCT] | Predicate | |
| [BRAHMS PCT LIA] | ||
| Non-clinical (Analytical) Comparison | ||
| Matrix Comparison | Serum similar to Plasma | |
| For a given patient, the same type of | ||
| sample tube must be performed for each | ||
| patient | Same | |
| Precision/ | ||
| Reproducibility | 6 samples tested in duplicate over 20 days | |
| total precision: 6.17 - 15.31% CV | ||
| intra-run precision: 1.93 - 4.61% CV | ||
| inter-run precision: 3.57 - 7.04% CV | ||
| inter-site precision: 4.21 - 11.40% CV | 14 samples tested in duplicate | |
| over 20 days | ||
| total precision: 5.3 - 16.6% CV | ||
| within run precision: 2.4-10% CV | ||
| Analytical Detection | ||
| Limit | 2 ng/ml = high risk of severe sepsis | |
| and/or septic shock | ||
| Trade/Device Name: VIDAS® BRAHMS PCT Regulation Number: 21 CFR 866.3210 Regulation Name: Endotoxin Assay Regulatory Class: Class II Product Code: NTM Dated: August 30, 2007 Received: September 4, 2007 |
Dear Ms. Mapp:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sally attym
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of the company name in a stylized font, with a graphic above it. The graphic is a circle that is half black and half white with vertical lines, with a curved line running through the center of the circle and down through the company name.
VIDAS® B.R.A.H.M.S PCT Assay Traditional 510(k) Submission
INDICATIONS FOR USE
510(k) Number (if known): K071146
Device Name: VIDAS BRAHMS PCT Assay
Indications for Use: VIDAS® BRAHMS PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS BRAHMS PCT assay is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission, for progression to severe sepsis and septic shock.
Prescription Use_ × (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 Device Evaluation (ODE)
Kudith te Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety