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K Number
K030628
Device Name
SAS RSV CONTROL KIT
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
2003-03-17

(18 days)

Product Code
JJX
Regulation Number
862.1660
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit.

The test is for professional use.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "SASTM RSV Control Kit."

This letter primarily focuses on:

  • Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
  • Regulatory Classification: Identifying the device as Class I and its regulation number and product code.
  • General Controls: Reminding the applicant of general control provisions of the Act (registration, listing, GMP, labeling, etc.).
  • Indications for Use: Confirming the intended use of the SASTM RSV Control Kit as controls for use with the SASTM RSV Test Kit.

The document does not include any performance data, study designs, sample sizes, ground truth methodologies, or expert qualifications that would be required to describe acceptance criteria and a study proving device performance against them.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.