(88 days)
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No
The document describes a quality control material for immunoassay tests and does not mention any AI or ML components or functionalities.
No.
This device is a quality control material intended to monitor the performance of clinical immunoassay test procedures, not to treat a condition or disease.
No
This device is a quality control material used to monitor the performance of diagnostic tests, rather than being a diagnostic device itself.
No
The device description clearly states it is a lyophilized human serum based assayed quality control material, indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs". This describes a product used in vitro (outside the body) to assess the accuracy and reliability of diagnostic tests.
- Device Description: The description confirms it's a "lyophilized human serum based assayed quality control material". Quality control materials are a key component of in vitro diagnostic testing workflows.
- Predicate Device: The mention of a predicate device (K020237; IMMUNOASSAY PLUS CONTROL Levels 1, 2 and 3) which is also an immunoassay control further supports its classification as an IVD.
The core function of this device is to be used in vitro to evaluate the performance of other diagnostic tests, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
LIGAND PLUS CONTROL is a fyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.
LIGAND PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.
Product codes (comma separated list FDA assigned to the subject device)
DIF, JJY
Device Description
LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.
Human origin components are added to a human serum based matrix. The product contains
§ 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.
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JAN 1 6 2004
Product Performance and Substantial Equivalency 510k 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.
The assigned 510(k) number is: _ Ko 333 44
- Submitter: Consolidated Technologies 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744-1832 Phone: (512) 445-5100 Fax:
October 2nd, 2003 Contact: Candice Betz Preparation date:
Product name (trade & common):
Proprietary: LIGAND PLUS CONTROL Level 1 - 3
Also sold as:
Consolidated Technologies will also sell this product as an unassayed OEM product, as well as an assayed OEM product. Individual customers will establish analyte assay criteria from the list of analytes provided. Consolidated Technologies will manufacture the product to the customer specifications (refer to Exhibit I). Customer specifications and Labeling criteria of OEM customers are maintained in the 510k file. Any regulatory compliance for labeling is the OEM Customers' responsibility.
Classification name:
Product code: DIF
CFR section: 21CFR 862.3280 Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Predicate device:
IMMUNOASSAY PLUS CONTROL Levels 1, 2 and 3 Consolidated Technologies, notification number K020237.
1
Product Performance and Substantial Equivalency
510(k) Summary (continued)
Device description:
LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.
Human origin components are added to a human serum based matrix. The product contains