(171 days)
Isolab Phenylalanine Test Kit
Not Found
No
The description details a standard laboratory assay using tandem mass spectrometry and does not mention any AI or ML components for data analysis or interpretation.
No
Explanation: This device is for screening and diagnosis of PKU, not for treatment or therapy. It quantifies substances in blood to identify newborns with PKU.
Yes
This device is intended for "screening for Phenvlketonuria (PKU)" and "will aid in identifying newborns with PKU," which are diagnostic purposes.
No
The device is a kit containing reagents and control material for a laboratory assay, which are physical components, not software. The analysis is performed on a tandem mass spectrometer, which is also hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "screening for Phenylketonuria (PKU)" and involves the "quantitative determination of phenylalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper." This is a diagnostic test performed on a biological sample (blood) outside of the body.
- Device Description: The description details a laboratory assay involving the extraction and analysis of dried blood spots using a tandem mass spectrometer. This is a typical process for an in vitro diagnostic test.
- Anatomical Site: The sample is "Blood specimens dried on filter paper," which is a biological sample.
- Intended User: The intended user is "Trained, qualified laboratory personnel," indicating it's used in a laboratory setting for diagnostic purposes.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
Product codes (comma separated list FDA assigned to the subject device)
JNB; CDR; JJE
Device Description
The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.
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
newborns
Intended User / Care Setting
trained, qualified laboratory personnel.
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)
Mean value/ standard deviation of 3679 samples run by:
Fluorometric method: X= 1.1 mg/dl S.D.= 0.3
Tandem Mass Method: X= 1.1 mg/dl S.D = 0.2
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.
Isolab Phenylalanine Test Kit
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
§ 862.1555 Phenylalanine test system.
(a)
Identification. A phenylalanine test system is a device intended to measure free phenylalanine (an amino acid) in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation.(b)
Classification. Class II.
0
OCT 2 8 2002
510(k) Summary
This summary of 510(k) safety and effectiveness information is being in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92.
The assigned 510(k) number is:________________________________________________-
Date: 3/28/01
Submitted by: PerkinElmer Life Sciences 3985 Eastern Rd. Norton, OH 44203
Telephone: 330-825-4525 Fax: 330-825-8520
Contact person: Hank Juske, Director, Regulatory Affairs
Trade name: NeoGram PKU Tandem Mass Spectrometry Kit (MS-7960) Common name: Phenylalanine screening test kit Classification name: Phenylalanine test system
Legally marketed predicate device: Isolab Phenylalanine Test Kit
Device description: The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.
Intended use: The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
Similarities/ Differences with the predicate device:
| Similarities: |
|---|
| -Intended use is the same. Both kits are for screening of newborns. |
| -Both kits are intended to screen for the defect PKU. |
| -Both measure the analyte Phenylalanine |
| -Both use dried blood spots on filter paper for sample collection |
| -Both use standards and controls dried onto filter paper |
| -Both assays are quantitative |
| -Sample size (3mm punched spot) is the same |
| -Both employ a 96 well microtiter plate |
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-Fluorometric based chemistry vs. spectrometric assay Differences: -Linearity of approximately 21mg/dl fluorometric vs. 35 mg/dl TMS -Measurement by calibration curve versus internal standard comparison -Zinc sulfate/ethanol extraction solution vs. methanol / water solution
Mean value/ standard deviation of 3679 samples run by:
Fluorometric method: X= 1.1 mg/dl S.D.= 0.3
Tandem Mass Method: X= 1.1 mg/dl S.D = 0.2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2002
Ms. Carroll Martin Regulatory Affairs Manager PerkinElmer Life Sciences, Inc. 3985 Eastern Road Norton, Ohio 44203
Re: K021541
Trade/Device Name: NeoGram PKU Tandem Mass Spectrometry Kit Regulation Number: 21 CFR 862.1555 Regulation Name: Phenylalanine test system Regulatory Class: Class II Product Code: JNB; CDR; JJE Dated: August 21, 2002 Received: August 22, 2002
Dear Ms. Martin:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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 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); 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 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PerkinElmer Life Sciences 3985 Eastern Rd. Norton, OH 44321 Phone: 330-825-4525 Fax330-825-8520 http://www.perkinelmer.com
INDICATIONS FOR USE STATEMENT
510(K) Number K021541
Device name: NeoGram PKU Tandem Mass Spectrometry Kit
Indications for use: The kit is intended for screening for phenylketonuria (PKU). It involves the quantitative determination of phenylalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
San Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices K 8 21 54 510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices |
Division of Clinical Laboratory Devices
510(k) Number K061541