(39 days)
Not Found
No
The document describes a set of calibrators for a folate assay, which are chemical reagents used to standardize the measurement of folic acid. There is no mention of any computational or algorithmic processing that would involve AI or ML. The calibration cards contain encrypted bar codes for concentration data, which is a standard data storage method, not indicative of AI/ML.
No.
This device is an in vitro diagnostic calibrator used to calibrate an assay, not a device intended to treat or manage a disease or condition.
No
Explanation: The device is described as "calibrators" intended to calibrate an assay, not to directly diagnose a condition. Calibrators are used to ensure the accuracy of a diagnostic assay.
No
The device description clearly indicates the device is a set of physical calibrators contained in vials, intended for use with an immunoassay system. It also mentions calibration cards with bar codes, which are physical components. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are used to calibrate an assay for the quantitative determination of folic acid levels in human serum, plasma, and red blood cells. This is a classic example of an in vitro diagnostic test, as it involves analyzing biological samples outside of the body to provide information about a person's health status.
- Device Description: The description details the composition and purpose of the calibrators, which are essential components for ensuring the accuracy of the Access Folate assay. Calibrators are used to establish a relationship between the signal measured by the assay and the actual concentration of the analyte (folic acid) in the sample. This is a fundamental aspect of quantitative in vitro diagnostic testing.
- Predicate Device: The mention of a predicate device (K060774; Access Folate Calibrator) further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and they are typically other IVDs.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to perform diagnostic testing on human biological samples.
N/A
Intended Use / Indications for Use
The Access Folate Calibrators are intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Access Folate Calibrators are a six level calibrator set intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay System. The calibrator set provides calibrators at six levels - zero and approximately 1.2. 3.1. 6.2, 12.4 and 24.8 ng/mL (2.8, 7.0, 14.0, 28.1, and 56.2 nmol/L). The calibrators are contained in 4.0 mL vials. The calibrator vials are intended for storage at -20°C or colder.
Calibration cards are provided with each calibrator kit. Calibration cards contain bar codes that are encrypted with the individual calibrator concentrations for each calibrator level.
Folate Calibrator S0 is intended for use with Access Folate assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator. Folate Calibrator S0 is a buffered matrix with human serum albumin (HSA) surfactant,
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
111952
Folate Calibrators Safety and Effectiveness 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name and Address
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: (952) 368-7858 Fax: (952) 368-7610 Contact: Kerrie Oetter
Date Prepared: July 22, 2011
Device Names
Proprietary Name: Access Folate Calibrators Common Name: Calibrator Classification Name: Calibrator
Predicate Device
Access Folate Calibrator Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
510(k) Number: K060774
Device Description
The Access Folate Calibrators are a six level calibrator set intended to calibrate the Access Folate assay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay System. The calibrator set provides calibrators at six levels - zero and approximately 1.2. 3.1. 6.2, 12.4 and 24.8 ng/mL (2.8, 7.0, 14.0, 28.1, and 56.2 nmol/L). The calibrators are contained in 4.0 mL vials. The calibrator vials are intended for storage at -20°C or colder.
Calibration cards are provided with each calibrator kit. Calibration cards contain bar codes that are encrypted with the individual calibrator concentrations for each calibrator level.
Folate Calibrator S0 is intended for use with Access Folate assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator. Folate Calibrator S0 is a buffered matrix with human serum albumin (HSA) surfactant,