LogoFDA 510(k) Search
K Number
K982578
Device Name
QUANTI-TEST SYSTEM
Manufacturer
PANATREX, INC.
Date Cleared
1998-09-02

(41 days)

Product Code
SCL,LDH
Regulation Number
880.5570
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Quanti-Test System is an allergen delivery system which, through a skin prick test, places antigen into the epidermis to indicate a sensitivity to allergens.

Device Description

The Quanti-Test System is an allergen delivery system.

AI/ML Overview

The provided documents are FDA 510(k) letters related to the Quanti-Test System, which is described as an "allergen delivery system" for skin prick tests. These documents are dated from 1998 and an administrative update from 2024. They primarily concern the regulatory classification and substantial equivalence determination for the device, not a study describing acceptance criteria and device performance in the context of recent AI-powered medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The documents confirm the following about the device:

  • Device Name: Quanti-Test System
  • Intended Use: An allergen delivery system which, through a skin prick test, places antigen into the epidermis to indicate a sensitivity to allergens.
  • Original Product Code (1998): LDH (Unclassified)
  • Updated Product Code (2024): SCL (Hypodermic single lumen needle, Class II)

The provided text does not contain any information about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study or human reader improvement with AI.
  6. Standalone performance of an algorithm.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for a training set.
  9. How ground truth for a training set was established.

These kinds of details are typically found in the 510(k) summary or detailed submission documents, which are not included in the provided snippets.

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).