Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics
Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics (Illinois): 510(k) cleared for Roche Diagnostics. Its amount of 140 is above the median of 138 (52nd percentile). Dated 15 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 140 · 52th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 13 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | DEN260027 |
| Device | Elecsys HBsAg II quant II RxDx |
| Applicant | Roche Diagnostics |
| Specialty / panel | Other |
| Product code | SJM |
| Clearance type | Direct |
| Decision | Unknown |
| Received | 2026-06-02 |
| Decision date | 2026-10-20 |
| Review time (days) | 140 |
| Third-party review | No |
| Applicant location | Indianapolis, IL, US |
| amount percentile | 52th of 414 (median 138, 1.0x median) |
| Peer records CSV (57 IL records) | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-20
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (IL first): SmartIPL_NI System (K241973) · Hyperdrive 35 Guidewire (K253146) · Tempus ECG-MR (K254297) · Ecomed Disposable Administration Sets (K254123) · TumorSight Risk (K260023) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics's amount: 52nd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 140-day review: this device is a strong predicate for similar products.
- Posted 15 days ago.
What is the FDAPulse record for Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics in Illinois?
Elecsys HBsAg II quant II RxDx (DEN260027) by Roche Diagnostics was cleared on 2026-10-20 after 140 days of review.
How does Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics compare to other Illinois FDAPulse records?
Its amount of 140 sits in the upper half (52th percentile) of 414 records; the median is 138. It is 15 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Elecsys HBsAg II quant II RxDx (DEN260027) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Elecsys HBsAg II quant II RxDx (DEN260027) | IL | 2026-10-20 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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