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

JLX — Predicate Candidate Screening

19 FDA 510(k) clearances under this product code; the 50 most recent screened below.

84 daysmedian FDA review time

518 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K100682	GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U	Wallac OY	2010-07-23	135
K081922	AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT	Wallac OY	2009-04-16	283
K062534	ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROX	Drg Intl., Inc.	2008-01-29	518
K060452	ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH	Neo-Genesis	2007-03-13	385
K050960	MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L K	Wallac OY	2005-07-11	84
K042424	DELFIA NEONATAL 17A-OH-PROGESTERONE KIT	Wallac OY	2004-09-30	22
K042425	AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT	Wallac OY	2004-09-30	22
K973350	BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST	Bio-Rad	1998-02-09	157
K934178	ACCUSCREEN 17-HYDROXYPROGESTERONE	Neometrics, Inc.	1995-03-30	580
K940233	NEOSCREEN ELISA HYDROXYPROGESTERONE	Pantex	1994-12-28	344
K943148	DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)	Diagnostic Systems Laboratories, Inc.	1994-11-10	133
K912026	DELFIA(R) 17 -OH-PROGESTERON KIT	Pharmacia Diagnostics, Inc.	1991-06-25	49
K911839	NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT	Pantex, Div. Bio-Analysis, Inc.	1991-06-18	54
K894265	DSL 17A-OH PROGERSTERONE (DSL #6800)	Diagnostic Systems Laboratories, Inc.	1989-09-07	77
K885198	17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA	Icn Biomedicals, Inc.	1989-02-23	69
K874782	COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT	Diagnostic Products Corp.	1988-02-11	84
K860335	COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT	Diagnostic Products Corp.	1986-04-24	85
K834246	PROGESTERONE TEST SET 125I 17-OH	Wien Laboratories, Inc.	1984-02-04	59
K771729	17-HYDROXYPROGESTERONE TEST SET	Wien Laboratories, Inc.	1977-10-21	37

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