|
510K # |
Product |
Cut-Off |
Product Code |
Notified: |
CLIA Status |
|
K020771 |
One Step Drug Screen Test Card; One Step Drug Screen Test Card With
Integrated Cup |
see below |
DJG; LCM; DKZ; DIS; JXM; LDJ; DIO; DPK; DJR |
May 15, 2002 |
|
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
MAMP |
1000 ng/mL |
|
|
|
|
|
MOP 300 or OPI 300 |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
OPI 2000 |
2000 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
K020313 |
One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug
Multi-Line Screen Test Device |
see below |
DKZ; DIO; LDJ; DJG; LCM; LAF |
May 8, 2002 |
|
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
MAMP |
1000 ng/mL |
|
|
|
|
|
OPI 2000 |
2000 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
K023946 |
One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug
Multi-Line Screen Test Device |
see below |
DJC; DJG; DIS; JXM; DJR; LFG |
Feb. 5, 2003 |
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
MOP 300 or OPI 300 |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K031759 |
Multi-Drug Multi Line Drug Screen Test Card with Integrated Cup |
|
LDJ; DIO; DJC; DKZ; DJG; LCM; JXM; DJR; DIS; LFG |
August 4, 2003 |
|
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
MAMP |
1000 ng/mL |
|
|
|
|
|
OPI 2000 |
2000 ng/mL |
|
|
|
|
|
MOP 300 |
300 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K011673 |
AMP - One Step Amphetamine Test Strip; One Step Amphetamine Test Device |
1000 ng/mL |
DKZ |
July 31, 2001 |
|
|
K041822 |
AMP - One Step Amphetamine Test Strip; One Step Amphetamine Test Device |
300 ng/mL |
DKZ |
July 6, 2004 |
|
|
K011672 |
mAMP - One Step Methamphetamine Test Strip; One Step Methamphetamine
Test Device |
1000 ng/mL |
LAF |
July 31, 2001 |
|
|
K033299 |
mAMP - One Step Methamphetamine Test Strip; One Step Methamphetamine
Test Device |
500 ng/mL |
LAF |
December 12, 2003 |
|
|
K012824 |
BAR - One Step Barbiturate Test Strip; One Step Barbiturate Test Device |
300 ng/mL |
DIS |
November 9, 2001 |
|
|
K012300 |
BZO - One Step Benzodiazepine Test Strip; One Step Benzodiazepine Test
Device |
300 ng/mL |
JXM |
September 17, 2001 |
|
|
K010841 |
COC - One Step Cocaine Test Strip; One Step Cocaine Test Device |
300 ng/mL |
DIO |
July 9, 2001 |
|
|
K032903 |
COC - One Step Cocaine Test Strip; One Step Cocaine Test Device |
150 ng/mL |
DIO |
February 17, 2004 |
|
|
K013380 |
MOP - One Step Opiate Test Strip; One Step Opiate Test Device |
300 ng/mL |
DJG |
December 18, 2001 |
|
|
K011353 |
OPI - One Step Opiate Test Strip; One Step Opiate Test Device |
2000 ng/mL |
DJG |
July 30, 2001 |
|
|
K011730 |
PCP - One Step Phencyclidine Test Strip; One Step Phencyclidine Test
Device |
25 ng/mL |
LCM |
August 9, 2001 |
|
|
K003557 |
THC - One Step Marijuana Test Strip; One Step Marijuana Test Device |
50 ng/mL |
LDJ |
March 15, 2001 |
|
|
K012595 |
MTD - One Step Methadone Test Strip; One Step Methadone Test Device |
300 ng/mL |
DJR |
October 15, 2001 |
|
|
K021526 |
TCA - One Step Tricyclic Antidepressants Test Strip; One Step Tricyclic
Antipressants Test Device |
1000 ng/mL |
LFG |
July 17, 2002 |
|
|
K022589 |
MDMA - One Step Ecstasy Test Strip; One Step Ecstasy Test Device |
500 ng/mL |
LAF |
October 28, 2002 |
|
|
K033047 |
OXY - One Step Oxycodone Test Strip or Test Device |
100 ng/mL |
DJG |
February 17, 2004 |
|
|
K040445 |
PPX - One Step Propoxyphene Test Strip or Test Device |
300 ng/mL |
JXN |
May 19, 2004 |
|
|
K023946 |
One Step Multi-Drug Multi-Line Screen Test Card; One Step Multi-Drug
Multi-Line Screen Test Device |
see below |
DJC; DJG; DIS; JXM; DJR; LFG |
February 5, 2003 |
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
MTD |
300 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
MOP or OPI |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K050050 |
ACON On Call Multi-Drug Home Test (AMP, THC, COC, MAMP, OPI, PCP) |
see above |
see above |
March 16, 2005 |
Waived |
|
K010582 |
ACON Strep A Rapid Test Strip |
|
GTY |
7-May-01 |
Waived K010582/A7 December 18, 2001 |
|
K023766 |
Strep A Twist Rapid Test Device |
|
GTY |
10-Feb-03 |
Waived |
|
K031784 |
Strep A Rapid Test Device |
|
GTY |
14-Jul-03 |
|
|
K024350 |
H. pylori Rapid Test Strip |
|
LYR |
April 2, 2003 |
|
|
K024350 |
H. pylori Rapid Test Device |
|
LYR |
April 2, 2003 |
Whole Blood - Waived |
|
K012252 |
QUIK-CHECK Ovulation Predictor Test (FLH-103/103H) |
|
CEP |
13-Sep-01 |
Auto Waived |
|
K012215 |
QUIK-CHECK Home Pregnancy Test (FHC-102H) |
|
LCX |
7-Aug-01 |
Auto Waived |
|
K993483 |
ACON One Step Home Pregnancy Test Strip (FHC-101H) |
|
LCX |
20-Jan-00 |
Auto Waived |
|
K993065 |
Acon Combo Pregnancy (FHC 202) |
|
JHI |
15-Oct-99 |
Urine Waived - Serum Moderate Complexity |
|
K993317 |
Acon hCG One Step Pregnancy Test Device (Urine) (FHC 102) |
|
JHI |
1-Dec-99 |
Waived |
|
K993203 |
ACON One Step Pregnancy Test Strip (Urine) (FHC-101 & FHC-111) |
|
JHI |
1-Dec-99 |
Waived |
|
K980736 |
ACON hCG Urine/Serum One Step Pregnancy Test (FHC-201 & FHC-211) |
|
JHI |
16-Apr-98 |
Urine Waived - Serum Moderate Complexity |
|
K983090 |
ACON Midstream Pregnancy Test (FHC-103) |
|
LCX |
18-Nov-98 |
Auto Waived |
|
N/A |
ACON LH One Step Ovulation Test Strip (Urine) (FLH-101) |
|
CEP |
Exempt |
Auto Waived |
|
N/A |
ACON LH One Step Ovulation Test Device (Urine) (FLH-102) |
|
CEP |
Exempt |
Auto Waived |
|
K032510 |
ACON Quik-Check II Midstream Home Pregnancy Test |
|
LCX |
22-Sep-03 |
|
|
K032661 |
ACON Quik-Check II Home Pregnancy Test Device |
|
|
|
|
|
K033041 |
ACON Quik-Check II Home Pregnancy Test Strip |
|
|
11-Dec-03 |
|
|
K041685 |
ACON Multi-CLIN Drug Screen Test Device |
|
DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG |
August 30, 2004 |
Moderate |
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
MOP 300 or OPI 300 |
300 ng/mL |
|
|
|
|
|
OXY |
100 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
|
PPX |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K041743 |
ACON Tri-Fect Drug Screen Test Device |
|
DKZ, DIS, JXM, DIO, LDJ, LAF, DJG, LCM, JXN, LFG |
September 9, 2004 |
Moderate |
|
|
AMP |
1000 ng/mL |
|
|
|
|
|
BAR |
300 ng/mL |
|
|
|
|
|
BZO |
300 ng/mL |
|
|
|
|
|
COC |
300 ng/mL |
|
|
|
|
|
THC |
50 ng/mL |
|
|
|
|
|
MDMA |
500 ng/mL |
|
|
|
|
|
MOP 300 or OPI 300 |
300 ng/mL |
|
|
|
|
|
OXY |
100 ng/mL |
|
|
|
|
|
PCP |
25 ng/mL |
|
|
|
|
|
PPX |
300 ng/mL |
|
|
|
|
|
TCA |
1000 ng/mL |
|
|
|
|
K042272 |
ACON Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma) |
|
KTN |
Feb. 28, 2005 |
Waived |
|
K042272 |
ACON Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma) |
|
KTN |
Feb. 28, 2005 |
Waived |