Accu-Chek Safe-T-Pro Uno Lancing Device by Roche Diabetes Care, Inc.

The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.

AI/ML Overview

The provided text is an FDA 510(k) premarket notification for the Accu-Chek Safe-T-Pro Uno Lancing Device. It does not describe a study with acceptance criteria in the manner typically found in clinical trials or AI/software validation studies. Instead, it details a "non-clinical bench testing" approach to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what is and isn't available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported device performance for specific metrics. Instead, it refers to "design verification and validation testing" performed per "applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850)." The conclusion states the device "performs as well or better than the legally marketed predicate device and legally marketed reference devices."

The closest approximation to "device performance" mentioned is:

The Accu-Chek Safe-T-Pro Uno lancing device is designed for a single use only and has a sharps injury prevention feature where the lancet is retracted and concealed before and after use, and is rendered inoperative after use.
It uses a 28 Gauge needle with a 1.5 mm depth and is spring-driven.
Loading/priming is not required; activation is via a press release button.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size used for the test set" or "data provenance" in terms of subject populations or data collection methods (retrospective/prospective). This is because the described testing is "non-clinical bench testing," meaning it was likely conducted in a laboratory setting on the device itself, rather than on human subjects or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as no "ground truth" established by experts for a test set is mentioned. The testing involves mechanical and design verification, not expert evaluation of results from human or image data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there's no expert review of outcomes.

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

Not applicable. A MRMC comparative effectiveness study is relevant for AI or diagnostic imaging devices evaluating human performance. This document is for a medical device (lancing device) and does not involve AI or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical bench testing would be engineering specifications, regulatory standards (like ISO or FDA special controls for sharps injury prevention), and the performance characteristics of the legally marketed predicate and reference devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary of what is present:

Type of Study: Non-clinical bench testing (design verification and validation testing).
Purpose: To demonstrate the mechanical functions, safety (sharps injury prevention), and performance are suitable for use and are substantially equivalent to legally marketed predicate and reference devices.
Applicable Standards: FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850).
Conclusion: The device is "safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices."
Clinical Testing: "Not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately."

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

November 13, 2023

Roche Diabetes Care, Inc. Kacia Mills Regulatory Affairs Consultant 9115 Hague Road Indianapolis, Indiana 46250

Re: K232509

Trade/Device Name: Accu-Chek Safe-T-Pro Uno Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 17, 2023 Received: August 18, 2023

Dear Kacia Mills:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.13 14:40:24 -05'00' Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K232509

Device Name Accu-Chek Safe-T-Pro Uno Lancing Device

Indications for Use (Describe)

The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Contact Details [21 CFR 807.92(a)(1)] Applicant Name: Roche Diabetes Care, Inc. Applicant Address: 9115 Hague Road Indianapolis, IN 46250-0457; United States of America Applicant Contact Telephone: +1 317-709-4223 Applicant Contact: Mrs. Kacia Mills Applicant Contact Email: kasey.mills@roche.com

Device Name [21 CFR 807.92(a)(2)]

Device Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Common Name: Blood Lancets Classification Names: Single use only blood lancet with an integral sharps injury prevention feature Regulation Number: 878.4850, Class II Product Code: FMK

Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]

Predicate #1: K220364 Predicate Trade Name: Accu-Chek Safe-T-Pro Uno Lancing Device Product Code: FMK

Legally Marketed Reference Devices [21 CFR 807.92(a)(3)]

Reference #1: K222090 Predicate Trade Name: Safety Lancet Product Code: FMK Reference #2: K221433 Predicate Trade Name: Facet 28G Universal Lancet Product Codes: QRK, QRL

Device Description Summary [21 CFR 807.92(a)(4)]

Intended Use/Indications for Use [21 CFR 807.92(a)(5)]

The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.

{4}------------------------------------------------

	Predicate Device - Accu-Chek Safe-T-Pro UnoLancing Device	Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device	Reference Device 1 -Safety Lancet (K222090)	Reference Device 2 - Facet28G Universal Lancet(K221433)		Predicate Device – Accu-Chek Safe-T-Pro UnoLancing Device	Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device	Reference Device 1 –Safety Lancet (K222090)	Reference Device 2 - Facet28G Universal Lancet(K221433)
Devicedescription	The Accu-Chek Safe-T-ProUno lancing device is aneedle used for capillaryblood sampling for use indiagnostic testing.The Accu-Chek Safe-T-ProUno lancing devicecontains a sharps injuryprevention feature wherethe lancet is retracted andconcealed before and afteruse. Once the lancet isused, it is renderedinoperative. The device isdesigned for single useonly.	The Accu-Chek Safe-T-ProUno lancing device is a needleused for capillary bloodsampling for use in diagnostictesting.The Accu-Chek Safe-T-ProUno lancing device contains asharps injury preventionfeature where the lancet isretracted and concealed beforeand after use. Once the lancetis used, it is renderedinoperative. The device isdesigned for single use only.	Safety Lancet, could bedivided into Model XY,Model XH, and Model XAaccording to the designfeatures and key functionalelements. The device issterilized by Gamma ray(Co-60 or e-beam) and forsingle use. The shelf life is 5years.	The Facet 28G Universal Lancet(Facet Lancet) is a sterile, singleuse, blood sampling device usedto obtain a sample of capillaryblood for diagnostic purposes,primarily for blood glucosemonitoring in diabetic patients.	Number ofUses	Single use only withintegral sharps injuryprevention feature	Same	Same	Single Use Only Blood LancetWithout An Integral SharpsInjury Prevention Feature andMultiple Use Blood Lancet ForSingle Patient Use Only
Indicationsfor Use	The Accu-Chek Safe-T-ProUno lancing device is asterile, single-use,disposable lancing deviceintended to be used byhealthcare professionals. Itis designed for capillaryblood sampling from thefingertip of adults andchildren 1 year and olderor, if the patient is a childunder 1 year, from the heel.	The Accu-Chek Safe-T-ProUno lancing device is intendedto produce a capillary bloodsample for testing utilizingsmall amounts of blood.	Safety Lancet is intended tobe used to obtain capillaryblood sample to performmedical testing, includingblood glucose monitoringand for tests using smallamounts of blood.	The Facet 28G Universal Lancetis a sterile, disposable single usedevice used to obtain a droplet ofcapillary blood for subsequentdiagnostic testing from the fingeror an alternative site, such as thepalm, upper arm, or forearm.The Lancet is to be properlydisposed of after a single use onan individual child, adolescent,or adult patient in home testing.	Deviceimages	Image: Predicate Device	Image: Candidate Device	Image: Reference Device 1Model XY Model XHImage: Model XY and Model XHModel XAImage: Model XA	Not available
IntendedUsers	Healthcare professionals	Healthcare professionals andconsumers	Consumers	Consumers	LancetSterility	Gamma irradiation	Same	Same	Same

Similarities / Differences Between Candidate, Predicate, and Reference Devices

{5}------------------------------------------------

{6}------------------------------------------------

	Predicate Device – Accu-Chek Safe-T-Pro UnoLancing Device	Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device	Reference Device 1 –Safety Lancet (K222090)	Reference Device 2 – Facet28G Universal Lancet(K221433)
NeedleGauge andDepth levels	28 Gauge needle – 1.5 mmdepth	28 Gauge needle – 1.5 mmdepth	Model XY Dimension/gauge:21G,23G,25G,26G,28G,30G (Needletype),1.2mm (Bladetype) Penetration depth:1.4mm-2.8mm(Needletype), 1.6mm-2.0mm(Blade type) Model XH Dimension/gauge:18G,21G,23G,28G(Needle type), 1.5mm(Blade type) Penetration depth:1.2mm-2.8mm(Needle type),1.6mm-2.0mm(Bladetype) Model XA Dimension/gauge:21G,23G,28G(Needle type) Penetration depth:1.3mm/1.8mm/2.3mm,1.5mm/2.0mm/2. 5mm(Needle type)	28 Gauge needle, multiple depthoptions depending on multipleuse blood lancet device usedwith single use only blood lancet
Mechanicalloading	Spring-driven	Same	Same	Same for multiple use bloodlancet device in which the singleuse blood lancet is used
	Predicate Device - Accu-Chek Safe-T-Pro UnoLancing Device	Candidate Device - Accu-Chek Safe-T-Pro UnoLancing Device	Reference Device 1 –Safety Lancet (K222090)	Reference Device 2 - Facet28G Universal Lancet(K221433)
Load andfiring	Loading / priming thedevice is not required.Press release button toactivate lancet mechanism.	Same	Same	Loading is required.
Anatomicalsites	Fingertip (adults andchildren 1 year and older)Heel (child under 1 year)	Same	Fingertip	Fingertip, palm, upper arm,forearm
Sharpsinjuryprevention	The Accu-Chek Safe-T-ProUno lancing device isdesigned with a sharpsinjury prevention feature.It is a passive safetymechanism thatautomatically activates afterthe device is used, requiringno action on the part of theuser. The lancet remains inthe housing before and afteruse. After activation, thesingle-use device cannot beused again.	Same	Same	N/A

{7}------------------------------------------------

{8}------------------------------------------------

Indications for Use Comparison [21 CFR 807.92(a)(5)]

The indications for use statement of the candidate device and of the predicate device are not identical. However, the intended use is the same, which is to obtain a blood sample testing. The package insert for the candidate device was updated to clearly separate indications for use and the intended test population.

Technological Comparison [21 CFR 807.92(a)(6)]

The technological characteristics of the candidate device are the same as the predicate.

Non-Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]

Nonclinical bench testing was performed per the applicable FDA Guidance documents (Sharps Injury Prevention Features) and special controls (878.4850). This includes (mechanical) design verification and validation testing in order to ensure the risks were appropriately managed, in addition to verifying that the device's mechanical functions are suitable for use over the lifetime of the device. See more in attached Verification Summary.

Clinical Testing is not applicable; risk analysis confirmed that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings. There were no special performance or safety concerns identified. See Risk documents provided in Biocompatibility section.

The Accu-Chek Safe-T-Pro Uno Lancing device is safe and effective for its intended use, and performs as well or better than the legally marketed predicate device and legally marketed reference devices.

Regulation Number and Section

§ 878.4850 Blood lancets.

(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.