(146 days)
For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Reagent is used on VITROS® Systems to quantitatively measure total homocysteine concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Performance Verifiers are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY 2 Reagents on VITROS® Systems.
The VITROS® Chemistry Products HCY 2 Reagent is used in conjunction with the VITROS® Chemistry Products Calibrator Kit 27 and VITROS® Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS® 5.1 FS Chemistry Systems, VITROS® 4600 Chemistry Systems, and the VITROS® 5600 Integrated Systems to quantitatively measure total homocysteine concentration in human serum and plasma.
The VITROS® Chemistry Products HCY 2 Reagent consists of one dual chambered reagent pack containing two ready-to-use liquid reagents, one in each chamber. Disulfide linked homocysteine (oxidized forms) in the sample is reduced by Tris (2-Carboxyethyl) Phosphine hydrochloride (TCEP) to form reduced homocysteine. Reduced homocysteine reacts with serine in the presence of cystathionine ß-synthase (CBS) to form Lcystathionine. L-cystathionine is broken down by cystathionine ß-lyase (CBL) to produce homocysteine, pyruvate and ammonia. Pyruvate is reduced to lactate by lactate dehydrogenase (LDH) using NADH as coenzyme. The concentration of homocysteine is directly proportional to the amount of NADH converted to NAD and is measured spectrophotometrically at 340 nm.
The VITROS® Chemistry Products Calibrator Kit 27 is prepared from an aqueous solution containing amino acids and inorganic acid. These standards are used to calibrate the VITROS® 5.1 FS Chemistry Systems, VITROS® 4600 Chemistry Systems, and VITROS® 5600 Integrated Systems for the quantitative measurement of homocysteine.
The VITROS® Chemistry Products HCY 2 Performance Verifiers I, II and III are prepared from processed human serum to which amino acid and preservative have been added. These are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY 2 Reagents on VITROS® Systems.
The VITROS® Chemistry Products FS Diluent Pack 2 (Saline/BSA) is a common reagent that is used by multiple assays on VITROS® Systems. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
Here's a breakdown of the acceptance criteria and study information for the VITROS® Chemistry Products HCY 2 Reagent and Performance Verifiers, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing hard-coded "acceptance criteria" in the traditional sense (e.g., a specific sensitivity or specificity threshold that must be met). Instead, the performance is evaluated through correlation studies and various bench testing parameters, compared against the predicate device.
The primary "acceptance criterion" for this type of submission is demonstrating substantial equivalence to the predicate device, which is concluded based on the presented data. The study compares the new device's performance to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (VITROS® HCY 2 Reagent) |
|---|---|---|
| Correlation with Predicate Device (VITROS® 5.1 FS Chemistry System) | Strong linear correlation (r approaching 1.0, slope near 1.0, intercept near 0) | y = 1.00 x + 0.42 (umol/L), r = 0.997 (n=110) |
| Correlation with Predicate Device (VITROS® 4600 Chemistry System) | Strong linear correlation (r approaching 1.0, slope near 1.0, intercept near 0) | y = 0.98 x + 0.60 (umol/L), r = 0.997 (n=123) |
| Correlation with Predicate Device (VITROS® 5600 Integrated System) | Strong linear correlation (r approaching 1.0, slope near 1.0, intercept near 0) | y = 0.99 x + 0.46 (umol/L), r = 0.993 (n=111) |
| Reportable Range | Comparable to predicate device (1.0-50.0 µmol/L) | 2.0-50.0 µmol/L |
| Sensitivity (LoQ) | Comparable to predicate device (0.96 µmol/L) | 1.29 µmol/L |
| Other Bench Testing | Precision, linearity, specificity, expected values, limit of detection, dilution, and specimen matrix considered comparable to predicate. | (Specific values not provided in summary) |
For the VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III, the acceptance criteria relate to their function as assayed controls and their equivalence to the predicate verifiers.
| Performance Characteristic (Verifiers) | Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (VITROS® HCY 2 Performance Verifiers) |
|---|---|---|
| Analytes Reported | Homocysteine | Homocysteine in VITROS® HCY and HCY 2 Reagents |
| Vial Volume | Acceptable for intended use (predicate 5 mL/vial) | 1.5 mL/vial |
| Intended Use Statement | Consistent with monitoring performance | Monitoring performance of VITROS® HCY and HCY 2 Reagents |
| Matrix | Processed human serum with preservatives | Processed human serum with preservatives |
| Product Type | Assayed Control | Assayed Control |
| Format | Liquid | Liquid |
| Number of levels | Three | Three |
| Nominal Values | Comparable to predicate device (7.0, 12, and 46 µmol/L) | 7.0, 12.5, and 25 µmol/L |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- VITROS® 5.1 FS Chemistry System: n = 110
- VITROS® 4600 Chemistry System: n = 123
- VITROS® 5600 Integrated System: n = 111
- Data Provenance: The data refers to "patient samples." The country of origin is not specified but is implicitly from a clinical setting, given the nature of the device. The data is retrospective, as it compares the new device to an already commercially available predicate device using these samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of immunoassay device submission does not typically involve human expert interpretation for "ground truth" establishment in the same way an imaging AI device would. The "ground truth" for the test set is effectively the quantitative measurement of total homocysteine concentration obtained by the predicate device (VITROS® Chemistry Products HCY Assay). Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply here in the context of human reviewers.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is established by the predicate device's quantitative measurements, not through expert adjudication of qualitative findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of homocysteine, not an imaging or AI interpretation device designed to assist human readers. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance studies of the device (reagent and verifiers) itself. It's an automated chemistry assay system, meaning it operates without continuous human intervention during the measurement process. The results are quantitative measurements directly produced by the system.
7. The Type of Ground Truth Used
The ground truth used for the comparative effectiveness study (correlation studies) was the quantitative measurement of total homocysteine concentration obtained by the predicate device (VITROS® Chemistry Products HCY Assay). This serves as the reference standard against which the new device's measurements are compared.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of an algorithm or machine learning model. This is a traditional IVD submission for a chemistry assay, not an AI/ML-based device. The development process would involve internal optimization and validation studies, but these are not typically referred to as "training sets" in the AI sense within such a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" with established ground truth as understood in AI/ML is not directly applicable here. The development of the assay would involve standard chemical and analytical methodologies to ensure accuracy and precision, with reference to known standards and controls, rather than human-curated ground truth for training an algorithm.
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5.0 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807:92.
The assigned 510(k) number is: _ K123930
- Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive name, address, Rochester, New York 14626-5101. (585) 453-3143 contact Contact Person: Michael Byrne
- December 19, 2012 2. Preparation Date
- Trade or Proprietary Names: 3. Device name VITROS® Chemistry Products HCY 2 Reagent VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III
Common Names: HCY assay and controls
Classification Names:
Urinary homocystine (nonquantitative) test system (21 CFR 862.1377) Class II
Quality Control material (assayed and unassayed) (21 CFR 862.1660) Class I (reserved). Since these devices (VITROS® HCY 2 Performance Verifiers I, II & III) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.
Product Code: LPS, JJX
Panel: Clinical Chemistry
Continued on next page
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-
- Predicate The VITROS® Chemistry Products HCY 2 assay is substantially equivalent to the previously cleared VITROS® Chemistry Products HCY Reagent Devices (K061588).
The VITROS® Chemistry Products HCY 2 Performance Verifiers are substantially equivalent to the previously cleared VITROS® Chemistry Products HCY Performance Verifiers (K061588).
- Predicate The VITROS® Chemistry Products HCY 2 assay is substantially equivalent to the previously cleared VITROS® Chemistry Products HCY Reagent Devices (K061588).
-
The VITROS® Chemistry Products HCY 2 Reagent is used in conjunction 5. Device description with the VITROS® Chemistry Products Calibrator Kit 27 and VITROS® Chemistry Products FS Diluent Pack 2 (BSA/Saline) on VITROS® 5.1 FS Chemistry Systems, VITROS® 4600 Chemistry Systems, and the VITROS® 5600 Integrated Systems to quantitatively measure total homocysteine concentration in human serum and plasma.
The VITROS® Chemistry Products HCY 2 Reagent consists of one dual chambered reagent pack containing two ready-to-use liquid reagents, one in each chamber. Disulfide linked homocysteine (oxidized forms) in the sample is reduced by Tris (2-Carboxyethyl) Phosphine hydrochloride (TCEP) to form reduced homocysteine. Reduced homocysteine reacts with serine in the presence of cystathionine ß-synthase (CBS) to form Lcystathionine. L-cystathionine is broken down by cystathionine ß-lyase (CBL) to produce homocysteine, pyruvate and ammonia. Pyruvate is reduced to lactate by lactate dehydrogenase (LDH) using NADH as coenzyme. The concentration of homocysteine is directly proportional to the amount of NADH converted to NAD and is measured spectrophotometrically at 340 nm.
The VITROS® Chemistry Products Calibrator Kit 27 is prepared from an aqueous solution containing amino acids and inorganic acid. These standards are used to calibrate the VITROS® 5.1 FS Chemistry Systems, VITROS® 4600 Chemistry Systems, and VITROS® 5600 Integrated Systems for the quantitative measurement of homocysteine.
The VITROS® Chemistry Products HCY 2 Performance Verifiers I, II and III are prepared from processed human serum to which amino acid and preservative have been added. These are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY 2 Reagents on VITROS® Systems.
The VITROS® Chemistry Products FS Diluent Pack 2 (Saline/BSA) is a common reagent that is used by multiple assays on VITROS® Systems. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 is prepared from processed water to which inorganic salt has been added. Diluent 2 is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added.
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-
- Device intended
VITROS® Chemistry Products HCY 2 Reagent: For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Reagent is used on VITROS® Systems to quantitatively measure total homocysteine concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
- Device intended
VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III: For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Performance Verifiers are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY® 2 Reagents on VITROS® Systems.
-
- Compari-VITROS® Chemistry Products HCY 2 Reagent is substantially equivalent to the VITROS® Chemistry Products HCY Reagent (K061588) (predicate son to predicate device) which was cleared by the FDA for IVD use. devices:
A least squares linear regression analysis using an n=110, demonstrated the following relationship: y = 1.00 x + 0.42 (umol/L) with a correlation coefficient (r) of 0.997 where y = results obtained using the VITROS® Chemistry Products HCY 2 assay and x = results obtained with the commercially available VİTROS® Chemistry Products HCY Assay in conventional/SI units (umol/L) on the VITROS 5,1 FS Chemistry System.
- Compari-VITROS® Chemistry Products HCY 2 Reagent is substantially equivalent to the VITROS® Chemistry Products HCY Reagent (K061588) (predicate son to predicate device) which was cleared by the FDA for IVD use. devices:
A least squares linear regression analysis using an n=123, demonstrated the following relationship: y = 0.98 x + 0.60 (umol/L) with a correlation coefficient (r) of 0.997 where y = results obtained using the VITROS® Chemistry Products HCY 2 assay on the VITROS® 4600 Chemistry System and x = results obtained with the commercially available VITROS® Chemistry Products HCY Assay in conventional/SI units (umol/L) on the VITROS 5,1 FS Chemistry System.
A least squares linear regression analysis using an n=111, demonstrated the following relationship: y = 0.99 x + 0.46 (umol/L) with a correlation coefficient (r) of 0.993 where y = results obtained using the VITROS® Chemistry Products HCY 2 assay on the VITROS® 5600 Integrated System and x = results obtained with the commercially available VITROS® Chemistry Products HCY Assay in conventional/SI units (umol/L) on the VITROS 5,1 FS Chemistry System.
The VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III are substantially equivalent to the VITROS® Chemistry Products HCY Performance Verifiers I, II & III (K061588) (predicate device) which was cleared by the FDA for IVD use.
In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS® Chemistry Products HCY 2 assay.
VITROS Chemistry Products HCY 2 assay and controls
uses
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Table 1 Similarities and differences of the assays performed using the VITROS® Chemistry Products HCY 2 Reagent and the VITROS® Chemistry Products HCY Reagent.
| DeviceCharacteristic | VITROS® HCY 2 Reagent(New device) | VITROS® HCY Reagent(Predicate device) |
|---|---|---|
| Intended Use | For in vitro diagnostic use only.VITROS Chemistry ProductsHCY 2 Reagent is used onVITROS® Systems toquantitatively measure totalhomocysteine concentration inhuman serum and plasma. Serumand plasma homocysteine levelscan assist in the diagnosis andtreatment of patients suspected ofhaving hyperhomocysteinemiaand homocystinuria. | Same, but specific to VITROSChemistry Products HCY Reagent |
| Reagent Packs | One dual chamber reagent packcontaining one reagent in eachchamber | Two dual chamber reagent packscontaining three reagents, onereagent in each of three chambers |
| Tests per pack/set | 50 tests/reagent pack/ 6 reagentpacks/carton=300 tests/carton | 50 tests/ 2 reagent packs/ 6reagent packs/carton=150tests/carton |
| Reactiveingredients | Lactate Dehydrogenase (LDH)=37.9 KU/LSerine=0.8 mmol/L (0.08% w/v)Nicotinamide AdenineDinucleotide (NADH)=0.5mmol/L (0.03% w/v)Tris (2-Carboxyethyl) phosphinehydrochloride (TCEP)=2.9mmol/L (0.08% w/v)Cystathionine β-lyase=16.4 KU/LCystathionine β-synthase=0.748KU/L | Lactate Dehydrogenase (LDH)=65 KU/LSerine=1.3 mmol/L (0.01% w/v)Nicotinamide AdenineDinucleotide (NADH)=0.56mmol/L (0.04% w/v)Tris (2-Carboxyethyl) phosphinehydrochloride (TCEP)=26.3mmol/L (0.8% w/v)Cystathionine β-lyase=16 KU/LCystathionine β-synthase=22KU/L |
| Analyte measured | Homocysteine | Same |
| Sample Type | Serum and plasma | Same |
| MeasurementType | Quantitative | Same |
| Reportable Range | 2.0-50.0 µmol/L | 1.0-50.0 µmol/L |
| DeviceCharacteristic | VITROS® HCY 2 Reagent(New device) | VITROS® HCY Reagent(Predicate device) |
| Sensitivity (LoQ) | 1.29 µmol/L | 0.96 µmol/L |
| Calibrator levels | Two levels (0, 28 µmol/L) | Same |
| Calibrator format | Liquid | Same |
| Calibrator matrix | Aqueous solution containingamino acids and inorganic acid | Same |
| Instrumentation | Automated clinical chemistryanalyzer | Same |
| CalibrationTraceabilityStandard | NIST 1955 | Same |
| Reference Interval | Males: 6.6 – 14.8 µmol/LFemales: 4.7 – 12.6 µmol/L | Same |
VITROS Chemistry Products HCY 2 assay and controls
·
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- Table 2 Similarities and differences of the device characteristics between the VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III with the predicate device VITROS® Chemistry Products HCY Performance Verifiers 1, II & III =
| DeviceCharacteristic | VITROS® HCY 2 PerformanceVerifiers(New Device) | VITROS® HCY PerformanceVerifiers(Predicate Device) |
|---|---|---|
| Analytes Reported | Homocysteine in VITROS® HCYand HCY 2 Reagents | Homocysteine in VITROS® HCYReagent |
| Vial Volume | 1.5 mL/vial | 5 mL/vial |
| Intended UseStatement | For in-vitro diagnostic use only.VITROS® Chemistry ProductsHCY 2 Performance Verifiers areassayed controls used to monitorperformance of VITROS® HCYand VITROS® HCY 2 Reagentson VITROS® Systems. | For in-vitro diagnostic use only.VITROS® Chemistry ProductsHCY Performance Verifiers areassayed controls used to monitorperformance of VITROS® HCYReagents on VITROS® System. |
| Matrix | The Performance Verifiers areprepared from processed humanserum with preservatives added. | Same |
| Product Type | Assayed Control | Same |
| Format | Liquid | Same |
| Number of levels | Three | Same |
| Nominal Values | 7.0, 12.5, and 25 µmol/L | 7.0, 12, and 46 µmol/L |
VITROS Chemistry Products HCY 2 assay and controls
.
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Conclusions:
The data presented in this premarket notification provide a reasonable assurance that the VITROS® Chemistry Products HCY 2 Reagent and the VITROS® Chemistry Products HCY 2 Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.
VITROS Chemistry Products HCY 2 assay and controls
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2013
Ortho-Clinical Diagnostics, Inc. C/O Michael Byrne 100 Indigo Creek Drive ROCHESTER NY 14626-5101
Re: K123930
Trade/Device Name: VITROS® Chemistry Products HCY 2 Reagent, VITROS® Chemistry Products HCY 2 Performance Verifiers I, II & III Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (nonquantitative) test system Regulatory Class: II Product Code: LPS, JJX Dated: April 03, 2013 Received: April 04, 2013
Dear Mr. Byrne:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Byrne
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K123930 |
|---|---|
| Device Name: | VITROS® Chemistry Products HCY 2 ReagentVITROS® Chemistry Products HCY 2 Performance Verifiers I, II, and III |
| Indications for Use: | For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Reagent is used on VITROS® Systems to quantitatively measure total homocysteine concentration in human serum and plasma. Serum and plasma homocysteine levels can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.For in vitro diagnostic use only. VITROS® Chemistry Products HCY 2 Performance Verifiers are assayed controls used to monitor performance of VITROS® Chemistry Products HCY and VITROS® Chemistry Products HCY 2 Reagents on VITROS® Systems. |
| Prescription Use | X AND/OR Over-The-Counter Use _______ |
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Image /page/8/Picture/3 description: The image shows the text "Yung W. Chan -S". The text is in a bold, sans-serif font. The letters "W", ".", "C", "h", "a", and "n" are stylized with a pattern of concentric lines. The text is black and the background is white.
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
| 510(k) | K123930 |
|---|---|
| -------- | --------- |
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§ 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.