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K Number
K181473
Device Name
DENV Detect NS1 ELISA
Manufacturer
InBios International, Inc.
Date Cleared
2018-08-27

(84 days)

Product Code
QCU
Regulation Number
866.3945
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The DENV Detect™ NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 - day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision.

This assay is not FDA cleared or approved for testing blood or plasma donors.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "DENV Detect™ NS1 ELISA", which is for the early detection of Dengue virus NS1 antigen. The document does not include information about acceptance criteria or specific study results to prove the device meets said criteria. It primarily covers the FDA's decision regarding substantial equivalence.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for the test set and data provenance.
  3. Number of experts used and their qualifications for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance results.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 866.3945 Dengue virus serological reagents.

(a)
Identification. Dengue virus serological reagents are devices that consist of antigens and antibodies for the detection of dengue virus and dengue antibodies in individuals who have signs and symptoms of dengue fever or dengue hemorrhagic fever. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus.(b)
Classification. Class II (special controls). The special control is FDA's guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).