# K213403: Aptiva CTD Essential Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Sep 29, 2023 after 711 days
- Product code: LLL (Extractable Antinuclear 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: 4 generations back to K000312 (2000). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152013: QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls, Inova Diagnostics, Inc. (2016) Summary page 7.
- K123593: Quanta Flash SM, Quanta Flash RNP, Quanta Flash SM Calibrators, Quanta Flash RNP Calibrators, Quanta Flash SM Controls,, Inova Diagnostics, Inc. (2013) Summary page 7.
- K954830: Orgentec Anti-SM (Smith) Pin Immuno Assay, Orgentec (1996) Summary page 7.
- K141655: Quanta Flash RO52, Quanta Flash RO52 Calibrators, and Quanta Flash RO52 Controls, Inova Diagnostics, Inc. (2015) Summary page 7.
- K141328: Quanta Flash RO60, Quanta Flash RO60 Calibrators, Quanta Flash RO60 Controls, Inova Diagnostics, Inc. (2015) Summary page 7.
- K141210: Quanta Flash SS-B, Quanta Flash SS-B Calibrators, and Quanta Flash SS-B Controls, Inova Diagnostics, Inc. (2015) Summary page 7.
- K152635: QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls, Inova Diagnostics, Inc. (2016) Summary page 7.
- K151429: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols, Inova Diagnostics, Inc. (2016) Summary page 7.
- K123880: Quanta Flash Centromere, Inova Diagnostics, Inc. (2014) Summary page 7.
- K981237: Quanta Lite Ribosome P Elisa, Inova Diagnostics, Inc. (1998) Summary page 7.

## Indications for use
The Aptiva CTD Essential Reagent consists of 10 multiplexed immunoassays utilizing particle-based multi-analyte technology for the quantitative determination of IgG autoantibodies against dsDNA, and semi-quantitative determination of IgG autoantibodies against RNP, Sm, Ro52, Ro60, SS-B, Scl-70, Jo-1, centromere, and Ribo-P in human serum: • The presence of dsDNA antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. • The presence of RNP antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of mixed connective tissue disease and systemic lupus erythematosus. • The presence of Sm antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. • The presence of Ro52 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren’s syndrome, systemic sclerosis, and idiopathic inflammatory myositis. • The presence of Ro60 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren’s syndrome. • The presence of SS-B antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus and Sjögren’s syndrome. • The presence of Scl-70 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. • The presence of Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myositis. • The presence of centromere antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic sclerosis. • The presence of Ribo-P antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of systemic lupus erythematosus. The individual assays included in the Aptiva CTD Essential Reagent are intended for use with the Inova Diagnostics Aptiva System.

Source page: https://510kreport.com/device/K213403
Methodology: https://510kreport.com/methodology