Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Disease Detection International, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
181 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | Disease Detection International, Inc. | 1994-10-25 | 111 | 0 |
| K925303 | PRO-STEP PT HCG | Disease Detection International, Inc. | 1993-06-15 | 237 | 0 |
| K925125 | PRO-STEP HCG | Disease Detection International, Inc. | 1993-01-13 | 92 | 0 |
| K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT | Disease Detection International, Inc. | 1991-07-19 | 86 | 0 |
| K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST | Disease Detection International, Inc. | 1990-09-05 | 90 | 0 |
| K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT | Disease Detection International, Inc. | 1990-08-09 | 28 | 0 |
| K895912 | IMMUNOCARD HCG II-S TEST KIT | Disease Detection International, Inc. | 1989-12-01 | 52 | 0 |
| K896109 | IMMUNOCARD STREP A TEST | Disease Detection International, Inc. | 1989-11-29 | 37 | 0 |
| K884246 | MODIFIED DDI SEROCARD HERPES IGG TEST KIT | Disease Detection International, Inc. | 1989-04-10 | 181 | 0 |
| K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT | Disease Detection International, Inc. | 1989-04-10 | 181 | 0 |
| K884247 | MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT | Disease Detection International, Inc. | 1989-04-10 | 181 | 0 |
| K884249 | MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT | Disease Detection International, Inc. | 1989-04-10 | 181 | 0 |
| K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | Disease Detection International, Inc. | 1989-03-14 | 169 | 0 |
| K883430 | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST | Disease Detection International, Inc. | 1989-01-30 | 168 | 0 |
| K881709 | IMMUNOCARD(TM) HCG II TEST KIT | Disease Detection International, Inc. | 1988-07-08 | 79 | 0 |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | Disease Detection International, Inc. | 1988-05-23 | 144 | 0 |
| K875361 | SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT | Disease Detection International, Inc. | 1988-05-13 | 134 | 0 |
| K875363 | SERODOT TOXOPLASMA IGG TEST KIT | Disease Detection International, Inc. | 1988-04-21 | 112 | 0 |
| K880410 | HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT | Disease Detection International, Inc. | 1988-04-05 | 64 | 0 |
| K875368 | THE DDI SERODOT RUBELLA IGG TEST KIT | Disease Detection International, Inc. | 1988-03-23 | 83 | 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