510(k) · Cleared
ClearedLyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige CO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Apr 24, 2014 as substantially equivalent to K832218 (Ventrex Laboratories, Inc., 1983) after a 115-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Apr 24, 2014
- Review
- 115 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832218 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK832218 Allergen Control InhalentVentrex Laboratories, Inc. · 1983
- This deviceK134013 Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige…Bio-Rad Laboratories · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832218 | Allergen Control Inhalent | Ventrex Laboratories, Inc. | 1983 | — |
| 0 (this device) | K134013 | Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control… | Bio-Rad Laboratories | 2014 | — |
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 JJY? 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? (1)
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 |
|---|---|---|---|
| * | K832218 | Allergen Control InhalentSummary page 1…Device to Which Substantial Equivalence is Claimed Baseline Allergen Controls - Inhalants Controls Ventrex Laboratories Predicate 510(k) Number: K832218 4.0 Description of Device Lyphochek Allergen sIgE Control is prepared from human serum source material with… | 1983 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Lyphochek Allergen sIgE Control Is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package Insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134013: Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative Minipak, Lyphochek Allergen Sige CO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134013
Report an extraction error
Are you the manufacturer?
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