(75 days)
Not Found
No
The device description details a spectrophotometric chemical reaction method for measuring cholinesterase activity. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on precision and method comparison, not AI/ML model performance metrics.
No.
The device is an in vitro diagnostic test used for the quantitative determination of cholinesterase activity to aid in the diagnosis and treatment of cholinesterase inhibition disorders, not to directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders."
No
The device description clearly states it is an "in vitro test" based on a chemical reaction measured spectrophotometrically, indicating it involves physical reagents and a spectrophotometer, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is an "in vitro test" and that the measurements are "used in the diagnosis and treatment of cholinesterase inhibition disorders." This clearly indicates it is used to examine specimens from the human body to provide information for diagnostic purposes.
- Device Description: The description further clarifies that it is an "in vitro test for the quantitative determination of the catalytic activity of cholinesterase in serum and plasma." Serum and plasma are biological specimens from the human body.
- Methodology: The test is based on a chemical reaction that occurs in vitro (outside the body) to measure the activity of an enzyme in a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in srum and plasma.
Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders.
Product codes (comma separated list FDA assigned to the subject device)
DIH
Device Description
The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase in serum and plasma. The test is based on the butyrylthiocholine method. Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocoline and butyrate. Thiocholine reduces the yellow substrate hexacyanoferrate III to the almost colorless hexacyanoferrate II. The decrease in color is measured spectrophotometrically. The calibrator is the Calibrator for automated systems (C.f.a.s; and the recommended control materials are Precinorm U or Precinorm U Plus; and Precipath U or Precipath U plus.
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, men, women aged 40 or more: 5320 - 12920 U/L
Women aged 16-39, not pregnant, not using hormonal contraceptives: 4260-11250
Women aged 18-41, pregnant or taking contraceptives: 3650-9120 U/L
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)
Comparison studies were conducted between the Cholinesterase Gen.2 Test System and the predicate device, Cholinesterase (K951595). Key results include:
- Measuring range: 200-14000 U/L (extended range after postdilution: 200 -28000 U/L)
- Lower Detection Limit: 200 U/L
- Within-run precision (%CV): 0.5% at 6374 U/L, 0.6% at 6263 U/L, 0.6% at 6015 U/L
- Between-run precision (%CV): 1.4% at 6374 U/L, 1.1% at 6263 U/L, 0.9% at 6015 U/L
- No significant interference from bilirubin.
- No significant interference up to H index of 350 (hemoglobin 350 mg/dL) and L index of 1000 (lipemia).
- Citrate and fluoride inhibit the reaction and must not be used.
- No significant interference from tested drugs.
- In rare cases, monoclonal gammopathy, in particular type IgM (Waldenstrom's macroglobulinemia) may cause unreliable results.
- For diagnostic purposes, results should always be assessed in conjunction with the patient's medical history and other findings.
- Method comparison results (Passing-Bablok): y = 0.970x + 128 (y = Integra Cholinesterase Gen.2, x = Integra cholinesterase (granulate)), T = 0.967; r = 0.999.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3240 Cholinesterase test system.
(a)
Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary
JUL - 3 2006
| 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 |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3723 | |
| Contact Person: Theresa M. Ambrose | |
| Date Prepared: April 18, 2006 | |
| Device Name | Proprietary name: Cholinesterase Gen.2 test system |
| Common name: Cholinesterase | |
| Classification name: Cholinesterase test system. | |
| Predicate devices | The Cholinesterase Gen.2 test system is substantially equivalent to the currently marketed Cholinesterase Test System cleared under K951595. |
| Device Description | The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase in serum and plasma. The test is based on the butyrylthiocholine method. Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocoline and butyrate. Thiocholine reduces the yellow substrate hexacyanoferrate III to the almost colorless hexacyanoferrate II. The decrease in color is measured spectrophotometrically. The calibrator is the Calibrator for automated systems (C.f.a.s; and the recommended control materials are Precinorm U or Precinorm U Plus; and Precipath U or Precipath U plus. |
1
510(k) Summary, Continued
The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative Intended use determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acycholine acylhydrolase) in serum and plasma.
Comparison to The below table compares the Cholinesterase Gen.2 Test System with the predicate predicate device, Cholinesterase (K 951595) device
Substantial equivalence: comparison table
| Characteristic | Cholinesterase Gen.2 Test
System | Predicate device
Cholinesterase Test System
(K951595) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for the quantitative determination
of the catalytic activity of
cholinesterase (EC 3.1.1.8;
acycholine acylhydrolase) in
serum and plasma. | for use on COBAS INTEGRA for the
quantitative determination of the
catalytic activity of cholineseterase
cholinesterase (EC 3.1.1.8;
acycholine acylhydrolase) in serum
and plasma. |
| Assay principle | Detection of catalytic activity via
spectrophotometric detection of
product. Butyrylthiocholine is
hydrolyzed by cholinesterase;
product reduces a yellow
substrate resulting in a colorless
product. | Detection of catalytic activity via
spectrophotometric determination
of product. S-butyrlthicholine
iodide is hydrolyzed by
cholinesterase; product reacts with
DTNB resulting in yellow product. |
| Instrument | same | COBAS Integra family of analyzers
(Integra 400/ 700/ 800) |
| Reagent
Stability | • Unopened kit: up to the stated
expiration date at 2-8 °C
• On board the analyzer: 4 weeks | • Unopened kit: up to the stated
expiration date at 2-8 °C
• On board the analyzer : 8 weeks |
| Reagent format | liquid | granulate |
| Reagent
composition | R1: Pyrophosphate, Potassium
hexacyanoferrate
R2: Butyrlthiocholine, GOOD's
buffer, stabilizers | R1: Phosphate, DTNB ( 5,5' -
dithiobis-2-nitrobenzoate
R2: s-butyrlthiocholine iodide |
| Sample type | Same | Human serum and plasma (EDTA,
heparin) |
2
| Traceability/
standardization | Standardized against a reference
method using a manual application
of the butyrlthiocholine/
hexacyanoferrate (III) method on a
photometer and the published molar
absorptivity of hexacyanoferrate
(III) | Manually against an internally
prepared reagent. |
| ---------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |
|---|
:
Continued on next page
.
:
.
: : :
3
510(k) Summary, Continued, Continued
・
.
Comparison to predicate (continued)
| Characteristic | Cholinesterase Gen.2 Test System | Predicate device
Cholinesterase Test System
(K951595) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring
range | 200-14000 U/L
Extended range after postdilution:
200 -28000 U/L | 0-25000 U/L |
| Lower
Detection Limit | 200 U/L | 4.5 U/L |
| Within-run
precision
(%CV) | • 0.5% at 6374 U/L
• 0.6% at 6263 U/L
• 0.6% at 6015 U/L | • 1.0% at 1728 U/L
• 0.99% at 9545 U/L |
| Between-run
precision
(%CV) | • 1.4% at 6374 U/L
• 1.1% at 6263 U/L
• 0.9% at 6015 U/L | • 2.2% at 1728 U/L
• 1.8% at 9545 U/L (total CV) |
| Limitations:
interferences | No significant interference from
bilirubin.
No significant interference up to
• H index of 350 (hemoglobin 350
mg/dL)
• L index of 1000 (lipemia)
Citrate and fluoride inhibit the
reaction and must not be used.
No significant interference from
tested drugs.
In rare cases, monoclonal
gammopathy, in particular typw
IgM (Waldenstrom's
macroglobulinemia) may cause
unreliable results.
For diagnostic purposes, results
should always be assessed in
conjunction with the patient's
medical history and other findings. | No significant interference from
hemolysis, icterus, lipemia.
Citrate and fluoride inhibit the
reaction and must not be used.
Propanolol causes artificially low
cholinesterase values at the tested
level.
Pathologically high levels of
albumin (7 g/dL) increase the
apparent cholinesterase activity
significantly |
| Characteristic | Cholinesterase Gen.2 Test
System | Predicate device
Cholinesterase Test System
(K951595) |
| Expected values | Children, men, women aged 40 or
more: 5320 - 12920 U/L
Women aged 16-39, not pregnant,
not using hormonal
contraceptives: 4260-11250
Women aged 18-41, pregnant or
taking contraceptives: 3650-9120 U/L | Females 3000 - 103000 U/L
Males 3500 - 114000 U/L |
| Method
comparison | y = Integra Cholinesterase Gen.2
x = Integra cholinesterase (granulate)
Passing-Bablok results: y=0.970x + 128. T = 0.967; r = 0.999 | |
Continued on next page
4
510(k) Summary, Continued, Continued
Comparison to predicate (continued)
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Theresa M. Ambrose Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
JUL - 3 2006
Re: K061093
Trade/Device Name: Cholinesterase Gen.2 Test System Regulation Number: 21 CFR§ 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Product Code: DIH Dated: April 18, 2006 Received: April 19, 2006
Dear Ms. Ambrose:
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 includions for use stated in the enclosure) to legally marketed predicate devices marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendminnts. 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, inting 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 Begistr.
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),
6
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 your device 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 (240) 276-0484. 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 tollifi the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutt
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: Cholinesterase Gen.2
Indications For Use:
The Cholinesterase Gen.2 Test System is an in vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in srum and plasma.
Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C.C.
Division Sign-Off
Office . ic Device Evalu ...
510(k) K0601093