510(k) · Cleared
Recalled · 2005Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · DHA System, Test, Human Chorionic Gonadotropin
Cleared on Dec 17, 2004 as substantially equivalent to K990222 (Diagnostic Products Corp., 1999) after a 79-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.
- Decided
- Dec 17, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- DHA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K911796 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK911796 Immulite (TM) HCGCirrus Diagnostics, Inc. · 1991
- 1 generation backK990222 Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2…Diagnostic Products Corp. · 1999 · Recalled
- This deviceK042676 Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin…Nichols Institute Diagnostics · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911796 | Immulite (TM) HCG | Cirrus Diagnostics, Inc. | 1991 | — |
| −1 | K990222 | Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6 | Diagnostic Products Corp. | 1999 | 1 |
| 0 (this device) | K042676 | Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay | Nichols Institute Diagnostics | 2004 | — |
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 |
|---|---|---|---|
| * | K990222 | Immulite HCG, Model LKCG1, LCCG5, Immulite 2000 HCG, Model L2KCG2, L2KCG6Summary page 1…e: System, Test, Human Chorionic Gonadotropin (hCG) 12.3. Predicate Device Substantial equivalence is claimed to the DPC's IMMIJLITE® hCG Immunoassay (K990222; Cleared 2/26/99). 12.4. Device Description The Nichols Advantage®~ Hyperglycosylated Human Chorionic Gonadotropin A… | 1999 |
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 |
|---|---|---|---|---|
| Aug 31, 2005 | Not classified | Z-0007-06 | Other | Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
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?
The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay (or simply: Nichols Advantage® H-hCG Assay) is intended for use with the Nichols Advantage® Specialty System for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG), a placental hormone in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. These diagnoses should be made with…
Read the full statement (152 words)
The Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay (or simply: Nichols Advantage® H-hCG Assay) is intended for use with the Nichols Advantage® Specialty System for the quantitative measurement of hyperglycosylated human chorionic gonadotropin (H-hCG), a placental hormone in human serum, or for the qualitative determination of H-hCG in urine as an aid in the detection of pregnancy. These diagnoses should be made with appropriate additional clinical evidence. Clinical considerations and professional judgment should be applied to any test device result as with this Nichols H-hCG chemiluminescent immunoassay.
The Nichols Advantage® H-hCG Assay is used in conjunction with two H-hCG calibrators which are used to calibrate the assay and are provided separately to the reagent cartridge. The control is used for the monitoring of the accuracy and precision of the Nichols Advantage H-hCG Assay and successful calibration is confirmed using three H-hCG controls also provided separately to the calibrators and reagent cartridge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042676 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042676: Nichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-HCG) Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042676
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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