# K123593: Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls,

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 17, 2013 after 147 days
- Product code: LKP (Anti-Sm Antibody, Antigen And Control)
- Device class: 2
- Regulation: 21 CFR 866.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922831 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922831: Quanta Lite SM Elisa, Inova Diagnostics, Inc. (1992) Summary page 2.
- K922833: Quanta Lite RNP Elisa, Inova Diagnostics, Inc. (1992) Summary page 3.

## Most influential descendants
- K213403: Aptiva CTD Essential Reagent (2023), 0 descendants of its own

## Indications for use
The QUANTA Flash Sm is a chemiluminescent immunoassay for the semi-quantitative determination of lgG anti-Sm antibodies in human serum. The presence of anti-Sm antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE). QUANTA Flash Sm Calibrators are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for the determination of lgG anti-Sm antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash Sm Controls are intended for use with the QUANTA Flash Sm chemiluminescent immunoassay for quality control in the determination of lgG anti-Sm antibodies in human serum. The QUANTA Flash RNP is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-ribonucleoprotein (RNP) antibodies in human serum. The presence of anti-RNP antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of Systemic Lupus Erythematosus (SLE) and Mixed Connective Tissue Disease (MCTD). QUANTA Flash RNP Calibrators are intended for use with the QUANTA Flash RNP chemiluminescent immunoassay for the determination of IgG anti-RNP antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash RNP Controls are intended for use with the QUANTA Flash RNP chemiluminescent immunoassay for quality control in the determination of lgG anti-RNP antibodies in human serum.

Source page: https://510kreport.com/device/K123593
Methodology: https://510kreport.com/methodology