K Number
K130963
Device Name
LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
Date Cleared
2013-05-06

(28 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Liquichek Pediatric Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Device Description
Liquichek Pediatric Control is prepared from bovine serum with added chemicals. therapeutic drugs, preservatives and stabilizers. The control is provided in liquid form for convenience.
More Information

Not Found

No
The summary describes a quality control serum for laboratory testing, with no mention of AI or ML in its description, intended use, or performance studies.

No
The device is described as an assayed quality control serum to monitor the precision of laboratory testing procedures, not to treat any disease or condition.

No
Explanation: The device is a quality control serum used to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.

No

The device description explicitly states the control is prepared from bovine serum and provided in liquid form, indicating it is a physical substance, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it is "intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert." This clearly indicates it is used in vitro (outside the body) to assess the performance of diagnostic tests.
  • Device Description: The description mentions it is prepared from bovine serum with added chemicals, therapeutic drugs, preservatives, and stabilizers, and is used in "laboratory testing procedures." This further supports its use in a laboratory setting for diagnostic purposes.
  • Predicate Device: The mention of a predicate device (K872227; Liquichek Pediatric Control) which is also a quality control material, strongly suggests that this type of product is regulated as an IVD.

Therefore, based on the provided information, the Liquichek Pediatric Control fits the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Liquichek Pediatric Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Product codes

JJY

Device Description

Liquichek Pediatric Control is prepared from bovine serum with added chemicals. therapeutic drugs, preservatives and stabilizers. The control is provided in liquid form for convenience.

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

Real-time stability studies were conducted to establish the thawed stability claims (opened-vial and unopened-vial). Accelerated stability studies were conducted to establish the shelf-life claims at -20 to -50°C. Product claims are as follows:
Thawed and Opened Stability: 14 days at 2 to 8°C
Thawed and Unopened Stability: 45 days at 2 to 8°C
Shelf Life Stability: 3 years at -20 to -50°C

Key Metrics

Not Found

Predicate Device(s)

K872227

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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K130963

510(k) Summary Liquichek Pediatric Control

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:

Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467

Date of Summary Preparation

April 2, 2013

2.0 Device Identification

Product Trade Name: Liquichek Pediatric Control Common Name: Multi-Analyte Controls, All Kinds (Assayed) Classifications: Class I, Reserved Product Code: JJY 21 CFR 862.1660 Regulation Number:

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Pediatric Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K872227

4.0 Description of Device

Liquichek Pediatric Control is prepared from bovine serum with added chemicals. therapeutic drugs, preservatives and stabilizers. The control is provided in liquid form for convenience.

5.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.

MAY 0 6 2013

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6.0 Intended Use

Liquichek Pediatric Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

7.0 Comparison of the new device with the Predicate Device

Liquichek Pediatric Control claims substantial equivalence to the Liquichek Pediatric Control currently in commercial distribution (K872227). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

Table 1: Similarities and Differences Between the New and Predicate Device

| Characteristics | Liquichek Pediatric Control
(New Device) | Liquichek Pediatric Control
(Predicate Device, K872227) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | This product is intended for use as an
assayed quality control serum to monitor the
precision of laboratory testing procedures for
the analytes listed in the package insert. | This product is intended for use as an
assayed quality control serum to monitor the
precision of laboratory testing procedures
for the analytes listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Bovine Serum | Bovine Serum |
| Thawed & Opened
Stability | 14 days at 2 to 8°C | 14 days at 2 to 8°C |
| Differences | | |
| Fill Volume | 2.5 mL | 4 mL |
| Thawed and
Unopened Stability | 45 days at 2 to 8°C or on-board
Dimension Vista at 2 to 8°C | 3 months at 2 to 8°C |
| Storage Unopened
(Shelf life) | At -20 to -50°C until the expiration date | At -20 to -70°C until the expiration date |
| Analytes | Contains:
Bilirubin, Direct
Bilirubin, Total
Caffeine
Calcium
Chloride
Glucose
Magnesium
Potassium
Sodium
Theophylline
Does not contain:
Bilirubin, Indirect
Bilirubin, Neonatal
Phenylalanine | Contains:
Bilirubin, Direct
Bilirubin, Indirect
Bilirubin, Neonatal
Bilirubin, Total
Caffeine
Calcium
Chloride
Glucose
Magnesium
Phenylalanine
Potassium
Sodium
Theophylline |

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8.0 Statement of Supporting Data

Real-time stability studies were conducted to establish the thawed stability claims (opened-vial and unopened-vial). Accelerated stability studies were conducted to establish the shelf-life claims at -20 to -50°C. Product claims are as follows:

Thawed and Opened Stability: Thawed and Unopened Stability: Shelf Life Stability: 14 days at 2 to 8°C 45 days at 2 to 8°C 3 years at -20 to -50°C

9.0 Conclusion

.

Based on the performance characteristics indicated above, the Bio-Rad Liquichek Pediatric Control is substantially equivalent to the predicate device, K872227.

All supporting data are retained on file at Bio-Rad Laboratories.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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 abstract image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mav 6. 2013

Bio-Rad Laboratories C/O Ms. Suzanne Parsons 9500 Jeronimo Road IRVINE CA 92618

Re: K130963

Trade/Device Name: Liquichek Pediatric Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: I, reserved Product Code: JJY Dated: April 02, 2013 Received: April 08, 2013

Dear Ms. Parsons:

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 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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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 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): K130963

Device Name: Liquichek Pediatric Control

Liquichek Pediatric Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 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)

YungWDChan-S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k):