Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics (Indiana): 510(k) cleared for Roche Diagnostics. Its amount of 249 is above the median of 138 (79th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 61/100. As of 2026-11-04, 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: 249 · 79th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 12 related IN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260221 |
| Device | Elecsys EBV EBNA IgG |
| Applicant | Roche Diagnostics |
| Specialty / panel | Microbiology |
| Product code | LSE |
| Device class | 1 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-26 |
| Decision date | 2026-10-02 |
| Review time (days) | 249 |
| Third-party review | No |
| Applicant location | Indianapolis, IN, US |
| amount percentile | 79th of 414 (median 138, 1.8x median) |
| Peer records CSV (13 IN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-02
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics and 13 Indiana peers
- Indiana FDAPulse records like this one: 13
- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics's amount: 79th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Indiana peer: $2,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 249-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 33 days ago.
What is the FDAPulse record for Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics in Indiana?
Elecsys EBV EBNA IgG (K260221) by Roche Diagnostics was cleared on 2026-10-02 after 249 days of review.
How does Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics compare to other Indiana FDAPulse records?
Its amount of 249 sits in the upper half (79th percentile) of 414 records; the median is 138. It is 33 days old, still within a typical 45-day follow-up window.
Elecsys EBV EBNA IgG (K260221) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Elecsys EBV EBNA IgG (K260221) | IN | 2026-10-02 | This record |
| Elecsys EBV VCA IgG (K260232) | IN | 2026-10-02 | Compare Elecsys EBV EBNA IgG (K260221) vs Elecsys EBV VCA IgG (K260232) → |
| Elecsys EBV IgM (K260233) | IN | 2026-10-02 | Compare Elecsys EBV EBNA IgG (K260221) vs Elecsys EBV IgM (K260233) → |
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- Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
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