510(k) · Cleared
Recalled · Class II · 2026Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyphen Biomed · LCO Platelet Factor 4 Radioimmunoassay
Cleared on Sep 7, 2007 as substantially equivalent to K003767 (Diagnostica Stago, Inc., 2001) and 1 other predicate after a 126-day review. Its family tree reaches back 2 generations to 1999. 1 of the 6 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 7, 2007
- Review
- 126 days
- Class
- Class II
- Product code
- LCO
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 2 generations to K983379 (1999). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK983379 Gti-PF4 ElisaGenetic Testing Institute · 1999
- 1 generation backK053559 PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 2006 · Recalled
- This deviceK071255 Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040AHyphen Biomed · 2007
- Descendant · cites it directly · 1 of its ownK170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK243374 HemosIL CL HIT-IgG (PF4-H)Instrumentation Laboratory (IL) Co. · 2025
Class I recalls in this family
- K170854 HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar…cites it directly · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983379 | Gti-PF4 Elisa | Genetic Testing Institute | 1999 | — |
| −1 | K053559 | PF4 Enhanced Solid Phase Elisa | Genetic Testing Institute | 2006 | 2 |
| 0 (this device) | K071255 | Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A | Hyphen Biomed | 2007 | — |
| +1 | K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls | Instrumentation Laboratory CO | 2017 | Class I |
| +2 | K243374 | HemosIL CL HIT-IgG (PF4-H) | Instrumentation Laboratory (IL) Co. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 1 |
| 2025 | 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.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCO device
- #1 K243374 HemosIL CL HIT-IgG (PF4-H)score 9.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K003767 | Asserachrom Hpia Test KitSummary page 1…t Kit (Stago) 2. PF4 ENHANCED Solid Phase ELISA (GTI) Predicate device 510 (k) number: 1. K003767 2. K053559 Description of the Device: The ZYMUTEST HIA is solid phase enzyme… | 2001 |
| * | K053559 | PF4 Enhanced Solid Phase ElisaSummary page 1…2. PF4 ENHANCED Solid Phase ELISA (GTI) Predicate device 510 (k) number: 1. K003767 2. K053559 Description of the Device: The ZYMUTEST HIA is solid phase enzyme linked immunosorbent assay (ELISA) des… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170854 | HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT Controls Class I | 2017 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2026 | Class II | Z-2171-2026 | Labeling Change Control | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. |
| Jul 19, 2019 | Class II | Z-2347-2019 | Under Investigation by firm | Residual crystallization of the microplate and recurrent negative controls out of range. |
| Jul 19, 2019 | Class II | Z-2346-2019 | Under Investigation by firm | Residual crystallization of the microplate and recurrent negative controls out of range. |
| Feb 5, 2018 | Class II | Z-1743-2018 | Packaging process control | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| Feb 5, 2018 | Class II | Z-1744-2018 | Packaging process control | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| Feb 5, 2018 | Class II | Z-1742-2018 | Packaging process control | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| Nov 9, 2011 | Class II | Z-1062-2018 | Other | A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results. |
| Nov 9, 2011 | Class II | Z-1063-2018 | Other | A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results. |
The 5 latest of 8 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K170854HemosIL AcuStar HIT-IgG (PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K170854 (Instrumentation Laboratory CO, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K003767.
How does its category compare?
All LCO devicesLCO Platelet Factor 4 Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LCO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCO
Too few LCO 510(k)s in any year since 2007 to give a median.
Recalls per year · LCO
3so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LCO
11in 2025
MAUDE reports naming product code LCO, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 2 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 0 | — | 3 (2) | — |
What is it indicated for?
ZYMUTEST HIA IgG and IgGAM kits are designed as a solid phase enzyme- linked immunosorbent assay (ELISA). These products are intended to be used as an in vitro diagnostics kit by Hematology, coagulation or other pathology laboratories to assist in screening patients samples for the presence of heparin- associated antibodies commonly found in patients with heparin induced thrombocytopenia or thrombosis (HIT).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071255 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071255: Zymutest Hia Iggam, Zymutest Igg, Model RK040D, RK040A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071255
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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