Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Helix Diagnostics, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
113 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-09-11 | 81 | 0 |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | Helix Diagnostics, Inc. | 2000-04-05 | 51 | 0 |
| K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | Helix Diagnostics, Inc. | 1998-05-12 | 104 | 0 |
| K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | Helix Diagnostics, Inc. | 1996-03-20 | 69 | 2 |
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | Helix Diagnostics, Inc. | 1995-12-15 | 63 | 6 |
| K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | Helix Diagnostics, Inc. | 1995-12-15 | 64 | 0 |
| K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | Helix Diagnostics, Inc. | 1995-08-24 | 101 | 0 |
| K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1995-07-18 | 88 | 0 |
| K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1995-07-17 | 90 | 0 |
| K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1994-04-20 | 75 | 0 |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1994-04-20 | 71 | 0 |
| K932850 | ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN | Helix Diagnostics, Inc. | 1993-09-24 | 106 | 0 |
| K932419 | ANTI-SS-B/LA ANTIBODY TEST | Helix Diagnostics, Inc. | 1993-08-05 | 79 | 0 |
| K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | Helix Diagnostics, Inc. | 1993-07-16 | 113 | 0 |
| K913041 | ANTI-DSDNA ANTIBODY TEST | Helix Diagnostics, Inc. | 1991-11-05 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda