510(k) · Cleared
Recalled · 2011MY Allergy Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunetech Corporation · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 19, 2002 as substantially equivalent to K993787 (Osborn Group, Inc., 2000) after a 120-day review. Its family tree reaches back 4 generations to 1986. It has been recalled 6 times.
- Decided
- Sep 19, 2002
- Review
- 120 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 4 generations to K861697 (1986). 6 ancestors in all, the oldest K851636 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK861697 Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 1986
- 3 generations backK971919 Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997
- 2 generations backK983172 Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998
- 1 generation backK993787 Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000 · Recalled
- This deviceK021698 MY Allergy TestImmunetech Corporation · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit) | Awareness Technology, Inc. | 1986 | — |
| −3 | K971919 | Ezchek/Hba Blood Collection Kit | Flexsite Diagnostics, Inc. | 1997 | — |
| −2 | K983172 | Accu-Base Hemoglobin A1C Sample Collection Kit | Diabetes Technologies, Inc. (Dti) | 1998 | — |
| −1 | K993787 | Appraise-Cardio Sample Collection Kit | Osborn Group, Inc. | 2000 | 3 |
| 0 (this device) | K021698 | MY Allergy Test | Immunetech Corporation | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1998 | 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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K993787 | Appraise-Cardio Sample Collection KitSummary page 2…me use by the iay conusmer. Substantial Equivalence Ciaim to: Appraise-Cardio Sample Coilection Kit K993787 Summary of Device Testing: Stability Studies were performed to obtain assurance that the whole blood sample… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2011 | Not classified | Z-0286-2012 | Material/Component Contamination | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. |
| Nov 4, 2011 | Not classified | Z-0287-2012 | Material/Component Contamination | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. |
| Nov 4, 2011 | Not classified | Z-0288-2012 | Material/Component Contamination | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. |
| Nov 4, 2011 | Not classified | Z-0290-2012 | Material/Component Contamination | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. |
| Nov 4, 2011 | Not classified | Z-0291-2012 | Material/Component Contamination | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. |
| Nov 4, 2011 | Not classified | Z-0289-2012 | Material/Component Contamination | ImmuneTech is recalling certain Specimen Collection Kits that contain Triad brand non-sterile alcohol prep pads which have been recalled by Triad Group, Hartland, WI due to Bacillus cereus, microbial contamination. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The MyAllergyTestTM is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTestTM is intended for use with the MyAllergyTestTM System. The MyAllergyTestTM is intended for home use by the lay consumer (Over-the-counter).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021698: MY Allergy Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021698
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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