(24 days)
Not Found
No
The device description focuses on the chemical reagents and calibrators used in an in vitro diagnostic test. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML.
No
This device is an in vitro diagnostic reagent used for quantitative determination of Homocysteine to assist in diagnosis, not for treating patients.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia." The term "assist in the diagnosis" clearly indicates its role as a diagnostic device.
No
The device description clearly outlines physical reagents (liquids in bottles) and calibrators, indicating it is a chemical reagent kit, 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" explicitly states it is "Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma". The term "in vitro" is a key indicator of an IVD, meaning it is used to test samples taken from the body, rather than being used directly on or in the body.
- Sample Type: The device is designed to analyze "serum and plasma," which are biological samples taken from a patient.
- Purpose: The purpose is to "assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia," which is a diagnostic purpose.
- Device Description: The description details reagents and calibrators used to perform a laboratory test on the biological samples.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended for the in vitro quantitative determination of total homocysteine in serum and plasma.
Indications For Use: Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.
Product codes (comma separated list FDA assigned to the subject device)
LPS
Device Description
The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration.
The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations.
The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
Performance: Correlation coefficient >0.95 (0.997) when compared to current Homocysteine Enzymic Homocysteine Reagent.
Precision (within run): Low - CV 2.3%, Mid - CV 1.8%, High - CV 1.3%.
Precision (total): Low - CV 4.3%, Mid - CV 2.8%, High - CV 2.4%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient >0.95 (0.997)
Precision (within run) CV: Low 2.3%, Mid 1.8%, High 1.3%
Precision (total) CV: Low 4.3%, Mid 2.8%, High 2.4%
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.
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Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'C' above the word 'CATCH'. The 'C' is designed as a three-dimensional, curved shape, giving it a modern and abstract appearance. The word 'CATCH' is written in a bold, sans-serif font, positioned directly below the 'C' symbol. The overall design is simple yet eye-catching, with a clear emphasis on the brand name.
Kob 2808
007 1 3 2006
Special 510(k) Summary
| 510(k)'s Owner Name: | Catch Incorporated |
|---|---|
| Address: | 11822 Northcreek Parkway North, Suite 107 |
| Bothell, WA 98011 | |
| Phone Number: | 425.402.8960 |
| Fax Number: | 425.402.8954 |
| Contact Person: | Glenn Kawasaki |
| Date of Preparation: | September 15, 2006 |
| Trade Name: | Liquid Stable (LS) 2-Part Homocysteine Reagent |
| Common Name: | Homocysteine Reagent |
Common Name: Classification Name:
Homocysteine Reage Urinary Homocystine (Nonquantitative) Test System
Device Description:
The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration.
The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations.
The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.
Intended Use:
Intended for the in vitro quantitative determination of total homocysteine in serum and plasma.
1
Kc62808
Summary of Technological Characteristics:
| | Liquid Stable (LS)
2-Part Homocysteine
Reagent | Homocysteine Enzymic
Homocysteine Reagent
K011689 | Comparison |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------|
| Intended Use | Intended for the in vitro
quantitative determination
of total homocysteine in
serum and plasma. | Intended for the in vitro
quantitative determination
of total homocysteine in
serum and plasma. | Same |
| Methodology | Clinical enzymatic
chemistry reagents;
2-part reagent | Clinical enzymatic
chemistry reagents;
2-part reagent | Same |
| Specimen
type | Serum and plasma | Serum and plasma | Same |
| Instrumentati
on | Standard clinical chemistry
analyzer | Standard clinical
chemistry analyzer | Same |
| Calibration | Calibrator provided
(0 µmoles/L and 25-30
µmoles/L) | Calibrator provided
(0 µmoles/L and 25-30
µmoles/L) | Same |
| Reagent
Formulations | Reagent LS R1 | R1A, R1B | Different |
| | Reagent LS R2 | R2 | Same |
| | Calibrators | Calibrators | Same |
| Performance | Correlation coefficient
0.95 (0.997) when
compared to current
Homocysteine Enzymic
Homocysteine Reagent | Correlation coefficient
0.95 (0.993) when
compared to Abbott FPIA
assay | Same |
| Precision
(within run) | Low - CV 2.3% | Low - CV 3.5% | Same |
| | Mid - CV 1.8% | Mid - CV 2.5% | |
| | High - CV 1.3% | High - CV 2.1% | |
| Precision
(total) | Low - CV 4.3% | Low - CV 5.6% | Same |
| | Mid - CV 2.8% | Mid - CV 4.7% | |
| | High - CV 2.4% | High - CV 3.8% | |
Similarities include: Intended use, methodology, specimen type, calibration requirements, and performance. Differences include: Modification of formulation-to improve reagent stability of R1 as compared to when Reagent R1A is mixed with Reagent R1B to give R1 in the Homocysteine Enzymic Homocysteine Reagent.
Conclusion based on similarities and differences: Liquid Stable (LS) 2-Part Homocysteine Reagent is substantially equivalent to the Homocysteine Enzymic Homocysteine Reagent.
:
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Catch Incorporated c/o Cindy Green, RAC Northwest Regulatory Support P.O. Box 1277 Maple Valley, WA 98038
OCT 1 3 2006
Re: K062808
Trade/Device Name: Liquid Stable (LS) 2-Part Homocysteine Reagent Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS Dated: September 29, 2006 Received: October 3, 2006
Dear Mr. Kawasaki:
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 marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, 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, isting 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 Degister.
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), and good mandated ing practi
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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 (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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutiérre
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
4
Indications for Use
510(k) Number (if known): K062808
Device Name: Liquid Stable (LS) 2-Part Homocysteine Reagent
Indications For Use:
Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.
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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
51004 K062808