(13 days)
Not Found
No
The summary describes a standard colorimetric assay for measuring enzyme activity and does not mention any AI or ML components.
No
The device is described as an "in vitro diagnostic reagent system" used to quantify alkaline phosphatase activity, which is then used in the diagnosis and treatment of diseases. It does not directly provide therapy.
Yes
This device is an in vitro diagnostic reagent system used for the quantitative determination of alkaline phosphatase in human serum and plasma, with measurements used in the diagnosis and treatment of various diseases.
No
The device description clearly indicates it is an in vitro diagnostic reagent system, which is a chemical substance used in a laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent system is "an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details a "colorimetric assay for the determination of the catalytic activity of alkaline phosphatase in serum or plasma," which is a laboratory test performed on biological samples outside of the body.
- Purpose: The intended use also mentions that the measurements are "used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases," further confirming its role in providing diagnostic information.
N/A
Intended Use / Indications for Use
The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Product codes
CJE
Device Description
The COBAS Integra ALP IFCC Gen.2 is a colorimetric assay for the determination of the catalytic activity of alkaline phosphatase in serum or plasma in accordance to the recommended reference method of the International Federation of Clinical Chemists (IFCC). In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by phosphatases into phosphate and p-nitro-phenol. The p-nitro-phenol released is directly proportional to the catalytic ALP activity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Children and Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
OCT 1 4 2003
..............................................................................................................................................................................
510(k) Summary - COBAS Integra ALP IFCC Gen.2
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831
Contact person: Sherri L. Coenen
Date prepared: September 29, 2003 |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra ALP IFCC Gen.2
Common name: Alkaline phosphatase Assay
Classification name: Alkaline phosphatase or isoenzymes test system |
| Device
description | The COBAS Integra ALP IFCC Gen.2 is a colorimetric assay for the
determination of the catalytic activity of alkaline phosphatase in serum or
plasma in accordance to the recommended reference method of the
International Federation of Clinical Chemists (IFCC). In the presence of
magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by
phosphatases into phosphate and p-nitro-phenol. The p-nitro-phenol released
is directly proportional to the catalytic ALP activity. |
| Intended use | The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS
Integra ALP IFCC Gen.2 Large (ALP2L) contains an in vitro diagnostic
reagent system intended for use on COBAS Integra systems for the
quantitative determination of the catalytic activity of alkaline phosphatase in
human serum and plasma. Measurements of alkaline phosphatase or its
isoenzymes are used in the diagnosis and treatment of liver, bone,
parathyroid, and intestinal diseases. |
1
510(k) Summary - COBAS Integra ALP IFCC Gen.2, continued
| Predicate
Device | We claim substantial equivalence to the currently marketed COBAS Integra
ALP IFCC Assay. (K981897). |
| --------------------- | -------------------------------------------------------------------------------------------------------- |
|---|
The following table describes the similarities and differences between the Reagent Summary COBAS Integra ALP IFCC Gen.2 and the predicate device.
| Topic | COBAS Integra ALP IFCC
(K981897) | COBAS Integra ALP IFCC Gen.2
(Modified Device) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassettes COBAS Integra ALP
IFCC (ALPL2 and ALPL6) contain
an in vitro diagnostic reagent system
intended for use on COBAS Integra
systems for the quantitative
determination of the catalytic activity
of alkaline phosphatase in serum and
plasma. | The cassettes COBAS Integra ALP
IFCC Gen.2 Small (ALP2S) and
COBAS Integra ALP IFCC Gen.2
Large (ALP2L) contain an in vitro
diagnostic reagent system intended
for use on COBAS Integra systems
for the quantitative determination of
the catalytic activity of alkaline
phosphatase in serum and plasma. |
| | | |
| Method | colorimetric assay in accordance with
the recommended reference method
of the International Federation of
Clinical Chemistry (IFCC) | Same |
| Sample type | Serum
Heparin plasma | Same |
| Measuring
range | 2 - 1500 U/L | 2 - 1200 U/L |
| Expected
values | Measured at 37° C
Adults
Females: 35 - 104 U/L
Males: 40 - 129 U/L
Children
1 day: Trade/Device Name: COBAS Integra ALP IFCC Gen.2 Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE Dated: September 29, 2003 Received: October 1, 2003
Dear Ms. Coenen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: COBAS Integra ALP IFCC Gen.2
Indications For Use:
The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Carol C. Benam/R. Jean Cooper. DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033185
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)