Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Elias U.S.A., Inc. — Predicate Candidate Screening

54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

118 daysmedian FDA review time

202 days90th percentile

54clearances measured

K-number	Device	Applicant	Decided	Review days
K964385	ELIAS ANA-HEP-2	Elias U.S.A., Inc.	1997-03-06	122
K963291	VARELISA ANA (4) PROFILE	Elias U.S.A., Inc.	1996-09-30	40
K953873	VARELISA HELICOBACTER PYLORI ANTIBODIES	Elias U.S.A., Inc.	1996-08-30	379
K953587	VARELISA MPO-ANCA	Elias U.S.A., Inc.	1996-01-26	178
K953586	VARELISA PR3-ANCA	Elias U.S.A., Inc.	1996-01-26	178
K951187	VARELISA CARDIOLIPIN ABS SCREEN	Elias U.S.A., Inc.	1995-10-02	200
K951205	VARELISA ANA PROFILE	Elias U.S.A., Inc.	1995-04-17	31
K951206	VARELISA PARIETAL CELL ANTIBODIES	Elias U.S.A., Inc.	1995-04-17	31
K944334	VARELISA COMBINED DNA ANTIBODIES EIA	Elias U.S.A., Inc.	1995-04-17	223
K951186	VARELISA ANA-4 SCREEN	Elias U.S.A., Inc.	1995-04-17	32
K951207	VARELISA HISTONE ANTIBODIES	Elias U.S.A., Inc.	1995-04-17	31
K950031	VARELISA DSDNA ANTIBODIES (FARR VERSION)	Elias U.S.A., Inc.	1995-03-10	65
K945607	VARELISA M2 ANTIBODIES	Elias U.S.A., Inc.	1995-01-24	70
K944171	VARELISA CENTROMERE ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K944170	VARELISA SM ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K944173	VARELISA JO-1 ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K944169	VARELISA RO (SS-A) ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K944172	VARELISA SCL-70 ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K944168	VARELISA LA (SS-B) ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K944167	VARELISA RNP-SM ANTIBODIES	Elias U.S.A., Inc.	1994-12-22	118
K940403	ELIAS CARDIOLIPIN ANTIBODIES	Elias U.S.A., Inc.	1994-09-20	236
K940622	ELIAS ENA SCREEN (MICROTITER PLATE)	Elias U.S.A., Inc.	1994-05-11	113
K940229	SYN ENA SCREEN (PIN PLATE)	Elias U.S.A., Inc.	1994-05-11	113
K940641	ELIAS ANA TOTAL	Elias U.S.A., Inc.	1994-03-25	39
K935468	SYNELISA ANA TOTAL	Elias U.S.A., Inc.	1994-03-25	133
K935469	SYNELISA DHEA-SULFATE	Elias U.S.A., Inc.	1994-03-22	139
K935288	SYNELISA CARDIOLIPIN ANTIBODIES	Elias U.S.A., Inc.	1994-01-24	82
K933392	ELIAS CARDIOLIPIN IGM ANTIBODIES	Elias U.S.A., Inc.	1993-12-08	149
K933393	ELIAS CARDIOLIPIN IGG ANTIBODIES	Elias U.S.A., Inc.	1993-12-08	149
K932206	SYNELISA ANA PROFILE	Elias U.S.A., Inc.	1993-12-03	211
K933128	SYNELISA PROGESTERONE	Elias U.S.A., Inc.	1993-11-05	130
K931177	SYNELISA CORTISOL	Elias U.S.A., Inc.	1993-09-27	202
K931255	SYNELISA CENP-B ANTIBODIES	Elias U.S.A., Inc.	1993-09-24	196
K933123	SYNELISA TG ANTIBODIES/TPO ANTIBODIES	Elias U.S.A., Inc.	1993-08-23	56
K932302	SYLNELISA HISTONE ANTIBODIES	Elias U.S.A., Inc.	1993-08-23	103
K930422	SYNELISA PARIETAL CELL ANTIBODIES	Elias U.S.A., Inc.	1993-08-03	189
K930209	SYNELISA RO ABS / LA ABS	Elias U.S.A., Inc.	1993-06-11	147
K930141	SYNELISA SM ABS/RNP-SM ABS	Elias U.S.A., Inc.	1993-05-11	119
K930142	SYNELISA U1-SNRNP (68KDA)-ANTIBODIES	Elias U.S.A., Inc.	1993-05-11	119
K930143	AYNELISA M2-ANTIBODIES	Elias U.S.A., Inc.	1993-05-11	119
K930281	SYNELISA JO-1 ANTIBODIES	Elias U.S.A., Inc.	1993-04-06	75
K930417	SYNELISA SCL-70 ANTIBODIES	Elias U.S.A., Inc.	1993-04-06	70
K930421	ELIAS DSDNA ABS	Elias U.S.A., Inc.	1993-03-10	43
K925922	ELIAS TGAB	Elias U.S.A., Inc.	1993-01-14	52
K925923	ELIAS TMAB	Elias U.S.A., Inc.	1993-01-14	52
K921132	SYN ELISA DSDNA ANTIBODIES	Elias U.S.A., Inc.	1992-12-01	266
K924421	SYNELISA CARDIOLIPIN ANTIBODIES	Elias U.S.A., Inc.	1992-11-30	90
K921787	SYNELISA TPO ANTIBODIES	Elias U.S.A., Inc.	1992-07-28	105
K921250	SYNELISA CARDIOLIPIN ANTIBODIES	Elias U.S.A., Inc.	1992-06-04	80
K920132	SYN ELISA BETA 2 MICROGLOBULIN TEST KIT	Elias U.S.A., Inc.	1992-05-28	136

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