510(k) · Cleared
Recalled · Class II · 2022Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Feb 26, 1999 as substantially equivalent to K911796 (Cirrus Diagnostics, Inc., 1991) after a 32-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 26, 1999
- Review
- 32 days
- Class
- Class II
- Product code
- DHA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911796 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK911796 Immulite (TM) HCGCirrus Diagnostics, Inc. · 1991
- This deviceK990222 Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2…Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 0 of its ownK042676 Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin…Nichols Institute Diagnostics · 2004 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K042676Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) AssayNichols Institute Diagnostics · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911796 | Immulite (TM) HCG | Cirrus Diagnostics, Inc. | 1991 | — |
| 0 (this device) | K990222 | Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6 | Diagnostic Products Corp. | 1999 | — |
| +1 | K042676 | Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay | Nichols Institute Diagnostics | 2004 | 1 |
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 DHA? 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 DHA device
- #1 K233581 VITROS Immunodiagnostic Products Total ß-hCG…score 7.6 · 2 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 |
|---|---|---|---|
| * | K911796 | Immulite (TM) HCGSummary page 2…he Devices: Diagnostic Products Corporation 5700 West 96" Street Los Angeles, CA 90045-5597 Euro/DPC — Not applicable DPC Registration number 1s 2017183 IMMULITE HCG (K911796, cleared 6/20/91) and IMMULITE 2000 HCG (K911796, cleared 4/27/97) IMMULITE HCG is a clinical use device intended for use with… | 1991 |
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 |
|---|---|---|---|
| K042676 | Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2022 | Class II | Z-1015-2022 | Under Investigation by firm | Potential for falsely elevated hCG results due to sample carryover in serum and urine patient samples, as well as quality control samples and adjustors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K042676 (Nichols Institute Diagnostics, 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DHA devicesDHA System, Test, Human Chorionic Gonadotropin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DHA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DHA
63in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DHA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DHA
234in 2025
MAUDE reports naming product code DHA, 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 | 64 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 1 | — | 0 | 196 |
| 2010 | 0 | — | 2 | 179 |
| 2011 | 0 | — | 0 | 478 |
| 2012 | 0 | — | 0 | 277 |
| 2013 | 2 | — | 0 | 244 |
| 2014 | 0 | — | 0 | 119 |
| 2015 | 1 | — | 2 | 52 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 101 |
| 2018 | 0 | — | 1 | 103 |
| 2019 | 1 | — | 0 | 152 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 3 | 289 | 0 | 210 |
| 2022 | 1 | — | 2 | 185 |
| 2023 | 3 | 63 | 0 | 194 |
| 2024 | 1 | — | 0 | 261 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IMMULITE HCG: For in vitro diagnostic use with the IMMULITE analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.
IMMULITE 2000 HCG: For in vitro diagnostic use with the IMMULITE 2000 analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.
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/K990222 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990222: Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990222
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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