(165 days)
Not Found
No
The device description details a standard enzymatic assay and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic assay used for the quantitative determination of total L-homocysteine. It assists in diagnosis and is used for calibration and quality control, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria."
No
The device description clearly outlines physical components (reagents, calibrators, controls) and a chemical reaction process measured spectrophotometrically, indicating it is a hardware-based in vitro diagnostic device, not software-only.
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 Homocysteine Enzymatic Assay is an "in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma". The calibrator and control kits are also intended for use with these in vitro methods.
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body to detect diseases, conditions, or infections. This description perfectly aligns with the stated use of this device.
The provided information clearly indicates that this device is designed to analyze biological samples (serum and plasma) outside of the body to provide diagnostic information (quantitative determination of homocysteine to assist in the diagnosis of hyperhomocysteinemia or homocystinuria).
N/A
Intended Use / Indications for Use
The Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The Homocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Product codes (comma separated list FDA assigned to the subject device)
LPS, JIX, JJX
Device Description
Assay:
The Homocysteine Enzymatic Assay is based on an enzyme cycling assay principle that assesses the co-substrate conversion product. In this assay, oxidized homocysteine (Hcy) is first reduced to free Hcy which then reacts with a co-substrate, S-adenosylmethionine, to form methionine and S-adenosylhomocysteine (SAH), catalyzed by a Hcy S-methyltransferase. SAH is assessed by coupled enzyme reactions where SAH is hydrolyzed into adenosine (Ado) and Hcy by SAH hydrolase, and Hcy is cycled into the Hcy conversion reaction to form a reaction cycle that amplifies the detection signal. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversions of NADH to NAD*. The concentration of Hcy in the sample is indirectly proportional to the amount of NADH converted to NAD which is measured spectrophotometrically at 340 nm.
Calibrator:
The Homocysteine Calibrator Kit is a liquid, ready-for-use calibrator based on human serum. It is a single level calibrator with lot specific values and diluted on board the analyzer to create a 5-point calibration curve.
Control:
The Homocysteine Control Kit consists of two ready-for-use controls based on human serum. The adjusted concentrations of the control components are in the low range for Control 1 and in the elevated range for Control 2.
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
Not Found
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): 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
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.
0
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter, name, address, contact
Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250 Phone: 317-521-3380 Fax: 317-521-2324
Contact person: Susan Hollandbeck Email: Susan.Hollandbeck@roche.com (317) 521-2324 Fax:
Date prepared: June 1, 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Device name
Proprietary name: Homocysteine Enzymatic Assay Common name: Homocysteine test system Classification name: Urinary homocystine (nonquantitative) test system under 21 CFR 862.1377 Product code: LPS
Calibrator: Proprietary name: Homocysteine Calibrator Kit Common name: Calibrator Classification name: 21 CFR 862.1150 Product code: JIX
Control:
Assay:
Proprietary name: Homocysteine Control Kit Common name: Quality control material (assayed and unassayed) Classification name: 21 CFR 862.1660 Product code: JJX
1
510(k) Summary, Continued
Device description
Assay:
The Homocysteine Enzymatic Assay is based on an enzyme cycling assay principle that assesses the co-substrate conversion product. In this assay, oxidized homocysteine (Hcy) is first reduced to free Hcy which then reacts with a co-substrate, S-adenosylmethionine, to form methionine and S-adenosylhomocysteine (SAH), catalyzed by a Hcy Smethyltransferase. SAH is assessed by coupled enzyme reactions where SAH is hydrolyzed into adenosine (Ado) and Hcy by SAH hydrolase, and Hcy is cycled into the Hcy conversion reaction to form a reaction cycle that amplifies the detection signal. The formed Ado is immediately hydrolyzed into inosine and ammonia which reacts with glutamate dehydrogenase with concomitant conversions of NADH to NAD*. The concentration of Hcy in the sample is indirectly proportional to the amount of NADH converted to NAD which is measured spectrophotometrically at 340 nm.
Calibrator:
The Homocysteine Calibrator Kit is a liquid, ready-for-use calibrator based on human serum. It is a single level calibrator with lot specific values and diluted on board the analyzer to create a 5-point calibration curve.
Control:
The Homocysteine Control Kit consists of two ready-for-use controls based on human serum. The adjusted concentrations of the control components are in the low range for Control 1 and in the elevated range for Control 2.
2
510(k) Summary, Continued
Intended use
Assav:
The Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
Calibrator:
The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Control:
The Homocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Predicate devices
Roche claims substantial equivalence for the Homocysteine Enzymatic Reagent to the currently marketed Diazyme Homocysteine Enzymatic Assay cleared in K061296 and K042448.
Roche claims substantial equivalence for the Homocysteine Calibrator and Controls to the currently marketed Diazyme Homocysteine Calibrator and Controls cleared in K071971 and K042448, respectively.
Substantial equivalence -Reagent
The following table compares the features of the draft device with the predicate device for the reagent.
Continued on next page
Confidential
3
510(k) Summary, Continued
Substantial equivalence - Reagent (continued)
| Feature | Predicate Device:
Diazyme Homocysteine
Enzymatic Assay (K061296) | Draft Device:
Homocysteine
Enzymatic Assay |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Assay is intended for the in vitro
quantitative determination of
total L-homocysteine in human
serum or plasma.
The reagents can assist in the
diagnosis and treatment of
patients suspected of having
hyperhomocysteinemia and
homocystinuria. | In vitro test for the quantitative
determination of L-
homocysteine in human serum
and plasma on Roche/Hitachi
cobas c systems.
The assay can assist in the
diagnosis of patients suspected
of having
hyperhomocysteinemia or
homocystinuria. |
| Sample Types | Serum, Lithium Heparin, and
EDTA | Serum, Lithium Heparin,
K2EDTA, and K3EDTA |
| Instrument
Platform | COBAS INTEGRA 400 | cobas c 501 |
| Calibrator | Homocysteine Calibrator;
single level, diluted to form
a 5-point calibration | same |
| Calibration
Frequency | Each lot + interval (168 hours) | Every 7 days,
after reagent lot change,
and as required following quality
control procedures |
| Calibration Mode | Logit/log5 | RCM |
| Controls | Homocysteine Controls | same |
Continued on next page
Page 4 of 9
4
510(k) Summary, Continued
Substantial equivalence - Reagent (continued)
| Feature | Predicate Device:
Diazyme Homocysteine
Enzymatic Assay (K061296) | Draft Device:
Homocysteine
Enzymatic Assay |
|-------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Reagent Active
Ingredients | R1: S-adenosylmethionine,
TCEP, 2-oxoglutarate, NADH | same |
| | R2: homocysteine S-
methyltransferase, glutamate
dehydrogenase, casein (bovine) | |
| | R3: adenosine deaminase
(bovine), S-adenosyl-
homocysteine hydrolase, casein
(bovine) | |
| Reagent Stability | Unopened:
2-8 °C until expiration date | Unopened:
2-8 °C until expiration date |
| | On-board in use:
60 days | On-board in use:
4 weeks |
| Measuring Range | 2.8 – 50 µmol/L | 3 – 50 µmol/L |
| Lower Limits of
Measure | LDL = 2.8 µmol/L | LoB = 3 µmol/L
LoD = 3 µmol/L |
Continued on next page
. . . . .
5
.
510(k) Summary, Continued
:
Substantial equivalence - Reagent (continued)
.
| Feature | Predicate Device:
Diazyme Homocysteine
Enzymatic Assay (K061296) | | | Draft Device:
Homocysteine
Enzymatic Assay | | | | |
|-----------------|---------------------------------------------------------------------------------------------------|--------------|---------------------|--------------------------------------------------|------------------|------------------|--------------------------|--------------------------------------|
| | | Value | CV
Within
Run | CV
Total
Precision | | Mean
Value | CV
Repeat-
ability | CV
Inter-
mediate
Precision |
| Precision | Hcy Low
Control | $7.0 \mu M$ | 2.6% | 2.7% | Hcy
Control 1 | $12.2 \mu mol/L$ | 1.5% | 2.1% |
| | Hcy High
Control | $29.0 \mu M$ | 2.3% | 3.4% | Hcy
Control 2 | $39.1 \mu mol/L$ | 1.8% | 2.0% |
| | Human
serum 1 | $11.0 \mu M$ | 2.5% | 3.6% | Human
serum 1 | $8.26 \mu mol/L$ | 2.0% | 2.3% |
| | Human
serum 2 | $15.6 \mu M$ | 1.9% | 2.4% | Human
serum 2 | $13.1 \mu mol/L$ | 1.8% | 2.1% |
| | | | | | Human
serum 3 | $30.0 \mu mol/L$ | 1.4% | 1.8% |
| | | | | | Human
serum 4 | $44.4 \mu mol/L$ | 2.0% | 2.2% |
| Expected Values | US: 15 μmol/L is used as the
cut-off value for normal levels of
homocysteine in adults. | | | | same | | | |
| | Europe: 12 μmol/L is used as the
cut-off value for normal levels of
homocysteine in adults. | | | | | | | |
6
510(k) Summary, Continued
Substantial equivalence - Reagent (continued)
| Feature | Predicate Device: | Draft Device: |
|---|---|---|
| Diazyme Homocysteine | Homocysteine | |
| Enzymatic Assay (K061296) | Enzymatic Assay | |
| Interferences | Patients who are taking | |
| methotrexate, carbamazepine, | ||
| phenytoin, nitrous oxide, | ||
| anticonvulsants, or 6-azuridine | ||
| triacetate, may have higher | ||
| levels of Hcy due to metabolic | ||
| interference with Hcy | ||
| metabolism | NOTE: Patients who are taking | |
| methotrexate, carbamazepine, | ||
| phenytoin, nitrous oxide, | ||
| anticonvulsants, or 6-azuridine | ||
| triacetate may have higher levels | ||
| of Hcy due to metabolic | ||
| interference with Hcy | ||
| metabolism. | ||
| S-Adenosylhomocysteine (SAH) | ||
| will cause a significant positive | ||
| interference. However, SAH is | ||
| only detectable at sub-nmol/L | ||
| concentrations in normal plasma, | ||
| and should not cause concern. | ||
| Icterus: | ||
| No significant interference | ||
| Hemolysis: | ||
| No significant interference up to | ||
| an H index of 100 | ||
| Hemolysis: | ||
| No significant interference | ||
| Lipemia: | ||
| No significant interference | Lipemia: | |
| No significant interference up to | ||
| an L index of 250 | ||
| Triglycerides: | ||
| No significant interference up to | ||
| 1790 mg/dl. | ||
| Drugs: | ||
| No interference was found at | ||
| therapeutic concentrations using | ||
| common drug panels. | ||
| Feature | Predicate Device: | |
| Diazyme Homocysteine | ||
| Enzymatic Assay (K061296) | Draft Device: | |
| Homocysteine | ||
| Enzymatic Assay | ||
| Interferences, | ||
| continued | Other: | |
| The following substances | ||
| normally present in the serum | ||
| produced less than 10% | ||
| deviation when tested at the | ||
| stated concentrations: 500 μM | ||
| NH4Cl, 1 mM NaPi, 1 mM NaF, | ||
| 0.5 mM Glutathione, 10 mM | ||
| Ascorbic Acid, 1 mM L- | ||
| Cysteine, 20 μM S- | ||
| Adenosylmethionine (SAM), | ||
| 100 μM Adenosine, 100 μM | ||
| Cystathionine | Additional drugs tested include | |
| Glutathione at 0.5 mmol/L, | ||
| Cystathionine at 100 μmol/L, | ||
| and Pyruvate at 0.5 mmol/L; no | ||
| interference was found. | ||
| Addition of 3-deazaadenosine to | ||
| inhibit Hcy production in red | ||
| cells has been suggested. | ||
| However, the Homocysteine | ||
| Enzymatic Assay can not use | ||
| samples containing 3- | ||
| deazaadenosine since it inhibits | ||
| one of the key enzymes used in | ||
| the assay. | Addition of 3-deazaadenosine to | |
| inhibit Hcy production in red | ||
| cells has been suggested. | ||
| However, the Homocysteine | ||
| Enzymatic Assay can not use | ||
| samples containing 3- | ||
| deazaadenosine since it inhibits | ||
| one of the key enzymes used in | ||
| the assay. |
In very rare cases, gammopathy,
in particular IgM
(Waldenstrom's
macroglobulinemia), may cause
unreliable results. |
Continued on next page
Confidential
7
510(k) Summary, Continued
Substantial equivalence - Reagent (continued)
8
510(k) Summary, Continued
The following table compares the features of the draft device with the Substantial equivalence predicate device for the calibrator. Calibrator
| Feature | Predicate Device:
Diazyme Homocysteine
Calibrator (K071971) | Draft Device:
Homocysteine Calibrator |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Diazyme Homocysteine
Calibrator is intended for use in
the calibration of quantitative
determination of Homocysteine
with the Diazyme Homocysteine
Enzymatic methods on COBAS
INTEGRA, cobas c, and Modular
P analyzers. | The Homocysteine Calibrator Kit
is intended for use in the
calibration of quantitative Roche
methods on Roche clinical
chemistry analyzers as specified in
the value sheets. |
| Analyte | Homocysteine | Same |
| Matrix | Human serum | Same |
| Storage | 2-8 °C | Same |
Substantial The following table compares the features of the draft device with the equivalencepredicate device for the control set. Control Set
| Feature | Predicate Device:
Diazyme Homocysteine
Controls (K042448) | Draft Device:
Homocysteine Control |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Diazyme Homocysteine
Controls are intended for use as
part of a quality assurance system
for the Diazyme Homocysteine
Enzymatic Assay | The Homocysteine Control Kit is
intended for use in quality control
by monitoring accuracy and
precision for the quantitative
methods as specified in the value
sheets. |
| Analyte | Homocysteine | Same |
| Matrix | 2 - level set with a normal
serum homocysteine level and
an abnormal homocysteine level | Same |
| Storage | 2-8 °C | Same |
. '
End of Summary
9
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized image of an eagle with its wings spread.
10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Susan Hollandbeck 9115 Hague Road P. O. Box 50416 Indianapolis, IN 46250
JUN - 5 2012
Re: K113793
Trade Name: Homocysteine Enzymatic Assay; Homocysteine Calibrator Kit, Homocysteine Control Kit
Regulation Number: 21 CFR §862.1377
Regulation Name: Urinary Homocysteine (non quantitative) test system Regulatory Class: Class II Product Codes: LPS, JIX, JJX Dated: May 23, 2012 Received: May 24, 2012
Dear Ms. Hollandbeck:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
10
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific ad view sor your stic Device Evaluation and Safety at (301) 796-5450. Also, comation of the regulation entitled, "Misbranding by reference to premarket notification" (2) proase note increading onlined, "Miser news of entreallance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of Surveinance and Drolliers of Solication of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
CI K Far 805), predsogo to maplefault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Tou may of amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html
Sincerely yours,
V.
Steven H. Lipton, Ph.D.
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use
510(k) Number (if known):
KIL3793
Device Name: Homocysteine Enzymatic Assay; Homocysteine Calibrator Kit; and Homocysteine Control Kit
Indications For Use:
The Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems. The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
The Homocysteine Calibrator Kit is intended for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
The Homocysteine Control Kit is intended for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Prescription Use (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) .
oncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113793
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