# K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Aug 12, 1997 after 57 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842280 (1984). 3 ancestors in all.
17 later devices descend from it; 6 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913124: Roche Reagent for Ammonia, Roche Diagnostic Systems, Inc. (1991) Summary page 3.
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 3.
- K842280: TDX Digitoxin, Abbott Laboratories (1984) Summary page 3.

## Most influential descendants
- K980996: Cobas Integra Carbon Dioxide (CO2-S), Cobas Integra Glucose HK Liquid (Glulf) (1998), 9 descendants of its own
- K031879: Cobas Integra Carbon Dioxide Assay (2003), 8 descendants of its own
- K032377: Roche Diagnostics Hitachi Bicarbonate Liquid (2003), 2 descendants of its own
- K183555: GEM Premier ChemSTAT (2019), 1 descendant of its own
- K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer (2006), 1 descendant of its own

## Recalls of this device
- Dec 3, 2007 · Not classified · Z-0688-2008: False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBAS INTEGRA 400 or COBA

## Indications for use
COBAS INTEGRA Ammonia (NH3): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the ammonia concentration in plasma (test NH3, 0-045). COBAS INTEGRA oAmylase EPS (AMYLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of amylase in serum, plasma (test AMY-L, 0998) and urine (test AMY-UL 0-999). COBAS INTEGRA Cholesterol (CHOLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol (test CHOLL, 0-001) and HDL - cholesterol concentration in serum and plasma in clinical laboratories. COBAS INTEGRA HDL - Cholesterol Application (HDLL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of total cholesterol and HDL - cholesterol (test HDLL, 0-002) concentration in serum and plasma in clinical laboratories. COBAS INTEGRA Creatinine Enzymatic (CREAE): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the creatinine concentration in serum (test CREAE, 0-014), and urine (test CREEU, 0-114). COBAS INTEGRA Digitoxin (DIGIT): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of digitoxin in serum or heparinized plasma (test DIGIT 0-259). COBAS INTEGRA Gamma - Glutamyltransferase (GGTL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2; y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTL, 0-599). COBAS INTEGRA Glucose HK Liquid (GLUCL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma (test GLUL, 0-991), urine (test GLULU, 0-992), and cerebrospinal fluid (test GLULC, 0-993). COBAS INTEGRA Lipase (LIPL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of lipase in serum and plasma (test LIPL, 0-200). COBAS INTEGRA Lysergic acid diethylamide (LSD) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the qualitative determination of lysergic acid diethylamide (LSD) in urine (test LSD, O-001) COBAS INTEGRA Urea/BUN (UREAL): contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the urea/BUN (blood urea nitrogen), in serum, plasma (test UREL, 0-003) and urine (test URELU, 0-004). Roche TDM OnLine Digitoxin Calibrators: are intended for use with the Roche reagents for Digitoxin and the COBAS Chemistry systems for the quantitative determination of digitoxin in serum and plasma. Roche TDM OnLine Digitoxin Controls: are quality control samples intended for use on COBAS chemistry systems with Roche reagents and calibrators for the quantitative determination of digitoxin assays.

Source page: https://510kreport.com/device/K972250
Methodology: https://510kreport.com/methodology