510(k) · Cleared
ClearedAthena Multi-Lyte Torch Igg Plus Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeus Scientific, Inc. · OPM Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Cleared on Jul 16, 2010 as substantially equivalent to K891781 (Zeus Scientific, Inc., 1989) and 3 other predicates after a 219-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jul 16, 2010
- Review
- 219 days
- Class
- Class II
- Product code
- OPM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K891781 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891781 Toxo Elisa Test SystemZeus Scientific, Inc. · 1989
- This deviceK093784 Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891781 | Toxo Elisa Test System | Zeus Scientific, Inc. | 1989 | — |
| 0 (this device) | K093784 | Athena Multi-Lyte Torch Igg Plus Test System | Zeus Scientific, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OPM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K891781 | Toxo Elisa Test SystemSummary page 3…al analytes are listed: Toxoolasma 1. Name of Predicate Device: Toxo lgG ELISA Test System 2. Manufacturer of Predicate Device: Zeus Scientific, Inc. 3. 51O(k)891781 Rubella 1. Name of Predicate Device: Rubella IgG ELISA Test System 2. Manufacturer of Predicate Device: Zeus Scientific, I… | 1989 |
| * | K891783 | Rubella Elisa Test SystemSummary page 3…Inc. 3. 51O(k)891781 Rubella 1. Name of Predicate Device: Rubella IgG ELISA Test System 2. Manufacturer of Predicate Device: Zeus Scientific, Inc. 3. S10(k)891783 CMVI 1. Name of Predicate Device: CMV lgG ELISA Test System 2. Manufacturer of Predicate Device: Zeus Scientific, Inc.… | 1989 |
| * | K924096 | CMV Elisa Test SystemSummary page 4…vice: Zeus Scientific, Inc. 7 3. S1O(k)924096 HSV-1 1. Name of Predicate Device: HerpeSelect 1 and 2 Immunoblot lgG 2. Manufacturer of Predicate Device: Focus Diagnos… | 1993 |
| * | K000238 | HSV-1 & HSV-2 Differentiation Immunoblot Igg, Model IB0900GSummary page 4…3. S1O(k)924096 HSV-1 1. Name of Predicate Device: HerpeSelect 1 and 2 Immunoblot lgG 2. Manufacturer of Predicate Device: Focus Diagnostics 3. 510(k)000238 HSV-2 1. Name of Predicate Device: HerpeSelect I and 2 Immunoblot lgG 2. Manufacturer of Predicate Device: Focus Diagnost… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All OPM devicesOPM Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OPM
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OPM
Too few OPM 510(k)s in any year since 2007 to give a median.
Recalls per year · OPM
No recall names OPM since 2007.
Adverse event reports per year · OPM
1in 2022
MAUDE reports naming product code OPM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH lgG Plus Test System is intended for the qualitative detection of specific human lgG class antibodies to Toxoplasma gondil (T.gondii), Rubella, Cytomnegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CIMV. For HSV 1 and HSV 2, the test isindicated for sexually active adults…
Read the full statement (134 words)
The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH lgG Plus Test System is intended for the qualitative detection of specific human lgG class antibodies to Toxoplasma gondil (T.gondii), Rubella, Cytomnegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CIMV. For HSV 1 and HSV 2, the test isindicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex l and Herpes Simplex 2.
The test is not intended for use in screening blood or plasma donors.
The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093784: Athena Multi-Lyte Torch Igg Plus Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093784
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026