510(k) · Cleared
Recalled · Class II · 2025Para Tech Plus Retics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · JCN Control, Cell Counter, Normal And Abnormal
Cleared on Nov 30, 1999 as substantially equivalent to K896154 (Streck Laboratories, Inc., 1989) after an 18-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Nov 30, 1999
- Review
- 18 days
- Class
- Class II
- Product code
- JCN
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896154 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK896154 Para Tech for Technicon H-1Streck Laboratories, Inc. · 1989
- This deviceK993825 Para Tech Plus ReticsStreck Laboratories, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK041240 Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041240Semen Analysis Quality Control, Assayed and UnassayedFertility Solutions, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896154 | Para Tech for Technicon H-1 | Streck Laboratories, Inc. | 1989 | — |
| 0 (this device) | K993825 | Para Tech Plus Retics | Streck Laboratories, Inc. | 1999 | — |
| +1 | K041240 | Semen Analysis Quality Control, Assayed and Unassayed | Fertility Solutions, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 JCN? 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 |
|---|---|---|---|
| * | K896154 | Para Tech for Technicon H-1Summary page 1…ara Tech Plus Retics Common Name: Assayed hematology control Classification Name: White and red cell (and reticulocyte) control (§ 864.8625) Predicate Device: Para Tech (K896154) manufactured by Streck" Laboratories Description: Para Tech Plus Retics is a suspension of stabilized human red blood cells, hu… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041240 | Semen Analysis Quality Control, Assayed and Unassayed | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2025 | Class II | Z-2088-2025 | Under Investigation by firm | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| Jun 4, 2025 | Class II | Z-2087-2025 | Under Investigation by firm | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
| Jun 4, 2025 | Class II | Z-2089-2025 | Under Investigation by firm | Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K041240 (Fertility Solutions, Inc., 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JCN devicesJCN Control, Cell Counter, Normal And Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JCN
FDA has decided no JCN device since 2007.
Median 510(k) review, days · JCN
Too few JCN 510(k)s in any year since 2007 to give a median.
Recalls per year · JCN
No recall names JCN since 2007.
Adverse event reports per year · JCN
2in 2007
MAUDE reports naming product code JCN, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 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 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Para Tech Plus Retics is intended to be used as a control for complete blood cell count (CBC), white cell five-part differential, and reticulocyte parameters on Bayer Advia 120 and Technicon H-Series hematology instruments.
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/K993825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993825: Para Tech Plus Retics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993825
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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