# K961053: Seraquest Rubella Igg

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Sep 4, 1996 after 170 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Rubella IgG Clin-ELISA kit, INCSTAR Corporation: named in the summary without a submission number

## Most influential descendants
- K091616: Bioplex 2200 MMRV Igg (2010), 2 descendants of its own
- K212769: DYNEX SmartPLEX MMRV IgG Assay Kit (2023), 0 descendants of its own
- K111072: Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl (2011), 0 descendants of its own

## Recalls of this device
- Jul 19, 2010 · Not classified · Z-2201-2011: The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
- Aug 20, 2008 · Not classified · Z-0908-2010: Elevated optical density (OD) values with the kit Negative Control.

## Indications for use
For the qualitative and quantitative detection of human IgG antibodies to Rubella in human serum by enzyme immunoassay, to aid in the determination of infection with rubella virus. When used as a qualitative test, SeraQuest Rubella 1gG aids in the assessment of the patient's immunological response to rubella. For manual use, or for use with the HyPrep System Plus.

Source page: https://510kreport.com/device/K961053
Methodology: https://510kreport.com/methodology